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The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal VMS, defined as follows:
The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brisdelle (paroxetine mesylate) | Experimental | Brisdelle (paroxetine mesylate) |
|
| Placebo Capsules | Placebo Comparator | Placebo Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brisdelle (paroxetine mesylate) | Drug | Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. | Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are:
| Week 4 and Week 12 |
| Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12 | Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | Week 4 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%) | A patient improvement scale questionnaire was used during participant visits. The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis: Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question "Compared to before starting the study medication, how would you describe your hot flushes now?" is 'Very much better' (1) or 'Much better' (2) or 'A little better' (3) and will be considered unsatisfied if their response to the same question is 'No change' (4) or 'A little worse' (5) or 'Much worse' (6) or 'Very much worse' (7). Receiver Operator Curve (ROC) analysis was performed on the combined data. Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corey Jacobs, MD | Principal Investigator | |
| Donna DeSantis, MD | Principal Investigator | |
| Robert Phillips, MD | Principal Investigator | |
| Louise Taber, MD | Principal Investigator | |
| Paige C. Brainard, MD | Principal Investigator | |
| Mark Stripling, MD | Principal Investigator | |
| Gioi Smith-Nguyen, MD | Principal Investigator | |
| Anthony Dulgeroff, MD | Principal Investigator | |
| Elise Kwon, MD | Principal Investigator | |
| Douglas Young, MD | Principal Investigator | |
| William Koltun, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmax Clinical Research | Mobile | Alabama | 36608 | United States | ||
| East Valley Family Physicians PLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25137243 | Derived | Pinkerton JV, Joffe H, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause. Menopause. 2015 Jan;22(1):50-8. doi: 10.1097/GME.0000000000000311. | |
| 24552977 | Derived | Portman DJ, Kaunitz AM, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause. Menopause. 2014 Oct;21(10):1082-90. doi: 10.1097/GME.0000000000000210. |
| Label | URL |
|---|---|
| Sponsor | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules | Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
| FG001 | Placebo Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo capsules | Drug | Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
| Week 4 and Week 12 |
| Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median | Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline. | Week 4 and Week 12 |
| Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. | Week 4 and Week 12 |
| Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. | Week 4 and Week 12 |
| Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | Week 4 and Week 12 |
| Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | Week 4 and Week 12 |
| Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median | The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido. The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21. The total GCS score ranges from "0" to "63" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below. | Week 4 and Week 12 |
| Percentage of Responders | Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below. | Week 4 and Week 12 |
| Percentage of Patient Global Improvement (PGI) Scale Responders (%) | Percentage of PGI Responders: Subject's overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of "Very Much Better" Or "Much Better" Or "A Little Better". Non Responders: Subjects with a Score of "No Change" Or "A Little Worse" Or "Much Worse" Or "Very Much Worse". Patient Global Improvement (PGI) scale is described below: Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed
| Week 4 and Week 12 |
| Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) | Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question. | Week 4 and Week 12 |
| Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score | The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12. | Week 4 and Week 12 |
| Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS) | Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes. The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question. | Week 4 and Week 12 |
| Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. | Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse". | Week 4 and Week 12 |
| Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression | Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12. | Week 4 and Week 12 |
| Assessment of Mood | Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from "65" to "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below. | Week 4 and Week 12 |
| BMI Change From Baseline (kg/m2), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index. | Week 4 and Week 12 |
| Principal Investigator |
| Dana Shipp, MD | Principal Investigator |
| Eric Ross, MD | Principal Investigator |
| Arthur Waldbaum, MD | Principal Investigator |
| Theodore Cooper, MD | Principal Investigator |
| J B. Stern, MD | Principal Investigator |
| Paul DiGrazia, MD | Principal Investigator |
| Robert Spitz, MD | Principal Investigator |
| James A Simon, MD | Principal Investigator |
| Mildred Farmer, MD | Principal Investigator |
| James Andersen, MD | Principal Investigator |
| Steven Bowman, MD | Principal Investigator |
| Rene Casanova, MD | Principal Investigator |
| Mary Yankaskas, MD | Principal Investigator |
| Andrew Kaunitz, MD | Principal Investigator |
| Ronald Surowitz, MD | Principal Investigator |
| Lisa Cohen, MD | Principal Investigator |
| Lisa Vendeland, MD | Principal Investigator |
| Tyrone Malloy, MD | Principal Investigator |
| Stephen C. Blank, MD | Principal Investigator |
| Mark Turner, MD | Principal Investigator |
| Carl R Lang, MD | Principal Investigator |
| Arthur Donovan, MD | Principal Investigator |
| Armen Arslanian, MD | Principal Investigator |
| Shiao-Yu Lee, MD | Principal Investigator |
| Gayle Moyer, MD | Principal Investigator |
| Geoffrey Turner, MD | Principal Investigator |
| Susan L Hendrix, MD | Principal Investigator |
| Mark Barber, MD | Principal Investigator |
| Stephen Swanson, MD | Principal Investigator |
| Timothy Sauter, MD | Principal Investigator |
| Steven Sussman, MD | Principal Investigator |
| Elizabeth Bretton, MD | Principal Investigator |
| Lance A. Rudolph, MD | Principal Investigator |
| Kenneth Levey, MD | Principal Investigator |
| Pouru Bhiwandi, MD | Principal Investigator |
| Richard E. Hedrick, MD | Principal Investigator |
| Gregory P Tarleton, MD | Principal Investigator |
| Mira Baron, MD | Principal Investigator |
| David J Portman, MD | Principal Investigator |
| Milroy Samuel, MD | Principal Investigator |
| Stuart Weprin, MD | Principal Investigator |
| James Liu, MD | Principal Investigator |
| Angelique Barreto, MD | Principal Investigator |
| Marvin Kalafer, MD | Principal Investigator |
| Larry S. Seidman, MD | Principal Investigator |
| Saul R. Berg, MD | Principal Investigator |
| Susan Floyd, MD | Principal Investigator |
| Scott Wilson, MD | Principal Investigator |
| Cynthia Strout, MD | Principal Investigator |
| D. S. Harnsberger, MD | Principal Investigator |
| Janet Dittus, MD | Principal Investigator |
| Gregg Lucksinger, MD | Principal Investigator |
| Anna Damian, MD | Principal Investigator |
| Sandra Hurtado, MD | Principal Investigator |
| Alfred Poindexter, MD | Principal Investigator |
| Nancy Campbell, MD | Principal Investigator |
| William Jennings, MD | Principal Investigator |
| Jose Ruiz, MD | Principal Investigator |
| John A. Hoekstra, MD | Principal Investigator |
| Peter A. Zedler, MD | Principal Investigator |
| Franklin Morgan, MD | Principal Investigator |
| Robin Kroll, MD | Principal Investigator |
| Derrick R Havin, MD | Principal Investigator |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Advanced Research Associates | Glendale | Arizona | 85308 | United States |
| Premier Research Group Limited | Peoria | Arizona | 85381 | United States |
| Verona Clinical Research, Inc | Tucson | Arizona | 85710 | United States |
| NEA Baptist Women's Clinic | Jonesboro | Arkansas | 72401 | United States |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| High Desert Medical Group | Lancaster | California | 93534 | United States |
| Facey Medical Foundation | Mission Hills | California | 91345 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| University Clinical Research | San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Apex Research Institute | Santa Ana | California | 92705 | United States |
| Downtown Women's Health Care | Denver | Colorado | 80218 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| The Women's Clinic of Northern Colorado | Fort Collins | Colorado | 80524 | United States |
| Danbury Clinical Research, LLC | Danbury | Connecticut | 06810 | United States |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| James A. Simon, MD, PC | Washington D.C. | District of Columbia | 20036 | United States |
| Meridien Research | Bradenton | Florida | 34208 | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | United States |
| DBC Research | Deerfield Beach | Florida | 33441 | United States |
| Clinical Physiology Associates | Fort Myers | Florida | 33916 | United States |
| University of Florida College of Medicine - Jacksonville Southside Women's Health | Jacksonville | Florida | 32207 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34684 | United States |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | United States |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Advanced Clinical Research | Boise | Idaho | 83642 | United States |
| Affinity Healthcare | Arlington Heights | Illinois | 60004 | United States |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | United States |
| Neurocare Center for Research | Newton | Massachusetts | 02459 | United States |
| ClinSite, LLC | Ann Arbor | Michigan | 48106 | United States |
| Professional Clinical Research | Benzonia | Michigan | 49616 | United States |
| Hutzel Womens Health Research | Detroit | Michigan | 48201 | United States |
| Professional Clinical Research | Interlochen | Michigan | 49643 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Lawrence Ob-Gyn Assoc., PC | Lawrenceville | New Jersey | 08648 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | United States |
| NY Center for Women's Health Research | New York | New York | 10038 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | United States |
| Complete Healthcare for Women | Columbus | Ohio | 43231 | United States |
| HWC Women's Research Center | Englewood | Ohio | 45424 | United States |
| University Hospitals of Cleveland Landerbrook Health Center | Mayfield Heights | Ohio | 44124 | United States |
| Sooner Clinical Research, Inc. | Oklahoma City | Oklahoma | 73112 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Philadelphia Clinical Research | Philadelphia | Pennsylvania | 19114 | United States |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | United States |
| Susan L Floyd, MD, PC | Wexford | Pennsylvania | 15090 | United States |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37043 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | United States |
| Advances In Health, Inc. | Houston | Texas | 77030 | United States |
| The Woman's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | United States |
| Research Across America | Katy | Texas | 77450 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | United States |
| Tidewater Clinical Research, Inc | Virginia Beach | Virginia | 23456 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| North Spokane Women's Clinic Research | Spokane | Washington | 99207 | United States |
| 24045678 | Derived | Simon JA, Portman DJ, Kaunitz AM, Mekonnen H, Kazempour K, Bhaskar S, Lippman J. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013 Oct;20(10):1027-35. doi: 10.1097/GME.0b013e3182a66aa7. |
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brisdelle (Paroxetine Mesylate) Capsules | Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
| BG001 | Placebo Capsules | Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. | Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are:
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Mean | Standard Deviation | Hot flash per day | Week 4 and Week 12 |
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| Secondary | Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%) | A patient improvement scale questionnaire was used during participant visits. The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis: Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question "Compared to before starting the study medication, how would you describe your hot flushes now?" is 'Very much better' (1) or 'Much better' (2) or 'A little better' (3) and will be considered unsatisfied if their response to the same question is 'No change' (4) or 'A little worse' (5) or 'Much worse' (6) or 'Very much worse' (7). Receiver Operator Curve (ROC) analysis was performed on the combined data. Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | Percentage of satisfied participants | Week 4 and Week 12 |
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| Secondary | Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median | Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes. The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Nightime awakenings | Week 4 and Week 12 |
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| Secondary | Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Hot flashes per week | Week 4 and Week 12 |
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| Secondary | Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Hot flashes per week | Week 4 and Week 12 |
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| Secondary | Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Hot Flash Severity scores per week | Week 4 and Week 12 |
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| Secondary | Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12. Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Hot Flash Severity scores per week | Week 4 and Week 12 |
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| Secondary | Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median | The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido. The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21. The total GCS score ranges from "0" to "63" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | units on a scale | Week 4 and Week 12 |
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| Secondary | Percentage of Responders | Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | percentage of participants | Week 4 and Week 12 |
|
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| Secondary | Percentage of Patient Global Improvement (PGI) Scale Responders (%) | Percentage of PGI Responders: Subject's overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of "Very Much Better" Or "Much Better" Or "A Little Better". Non Responders: Subjects with a Score of "No Change" Or "A Little Worse" Or "Much Worse" Or "Very Much Worse". Patient Global Improvement (PGI) scale is described below: Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed
| The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | percentage of participants | Week 4 and Week 12 |
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| Secondary | Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS) | Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered). The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | percentage of participants | Week 4 and Week 12 |
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| Secondary | Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score | The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Mean | Standard Deviation | units on a scale | Week 4 and Week 12 |
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| Secondary | Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS) | Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes. The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | Percent of participants | Week 4 and Week 12 |
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| Secondary | Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale. | Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS) The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Responders: Subjects Achieving a Score of "Very Much Improved" Or "Much Improved" Or "Minimally Improved". Non Responders: Subjects with a Score of "No Change" Or "Minimally Worse" Or "Much Worse" Or "Very Much Worse". | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | percentage of participants | Week 4 and Week 12 |
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| Secondary | Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression | Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS). The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety. Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression). Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed). Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale. The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | Percentage of participants | Week 4 and Week 12 |
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| Secondary | Assessment of Mood | Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from "65" to "325." Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Number | Percent of participants | Week 4 and Week 12 |
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| Secondary | BMI Change From Baseline (kg/m2), Median | Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary. Assessment of the effect of Brisdelle compared with placebo on body mass index. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Median | Full Range | Change from baseline BMI kg/m2 | Week 4 and Week 12 |
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| Primary | Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12 | Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below. | The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Mean | Standard Deviation | Hot Flash Severity score per day | Week 4 and Week 12 |
|
12 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brisdelle (Paroxetine Mesylate) Capsules | Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 | 2 | 301 | 134 | 301 | ||
| EG001 | Placebo Capsules | Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 | 1 | 305 | 129 | 305 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dental discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bloody discharge | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Energy increased | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ear lobe infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Food craving | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Crying | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anorgasmia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Elevated mood | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal blistering | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sweat gland disorder | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Mole excision | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Scar excision | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sailaja Bhaskar, Executive Director, Clinical Research | Noven Therapeutics, LLC | (212) 287-0798 | sbhaskar@noven.com |
| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Week 12 |
|
Week 12 frequency |
| No |
| Superiority or Other |
| OG001 | Placebo Capsules | Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Placebo Capsules |
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
| Placebo Capsules |
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
| OG001 | Placebo Capsules | Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
| OG001 |
| Placebo Capsules |
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
| Placebo Capsules |
Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 |
|
|
|
|
|
|
|