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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK065209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.
The current trial is recruiting newly diagnosed adults who have not yet received treatment. Approximately 270 participants will be randomly assigned to take up to 75 milligrams of amitriptyline or a placebo each day for 14 to 26 weeks. All participants will be given techniques to practice suppressing the urge to urinate for increasingly longer stretches until they can wait 3 or 4 hours before going to the bathroom. Participants will also regulate when and how much they drink and avoid bladder irritants such as alcohol, acidic foods and carbonated or caffeinated drinks. Staff and patients will find out who received the amitriptyline when the study is finished. Medications and tests are free to participants.
Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC).The centers make up the Interstitial Cystitis Clinical Research Network, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at NIH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Amitriptyline | Active Comparator | Amitryptiline, increased during a 6-week period from 10 mg up to 75 mg, taken once daily for a total of 12 weeks. |
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| 2 - Placebo | Placebo Comparator | Placebo will be dosed exactly as the active arm and taken once daily for a total of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amitriptyline | Drug | Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Response Assessment (GRA) | The primary efficacy analysis was based on intent to treat, comparing the proportion of responders between treatment arms on a patient reported GRA recorded at 12 weeks or study withdrawal. The 7-point GRA queried, "As compared to when you started the current study, how would you rate your overall symptoms now?" The 7 response options were markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. Participants who indicated that they were markedly or moderately improved were considered responders. Subjects who withdrew from the study for any reason and did not provide data on the primary outcome were considered treatment failures, and were included in the denominator for calculation of response rates. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life Measures From Baseline to 12 Weeks | A number of secondary outcomes [as detailed in the Baseline Measures section] were assessed throughout the study. These outcomes include pain, urgency and frequency on 0 to 10-point Likert scales, a 24-hour voiding diary, the Health Status Questionnaire for Quality of Life (SF-36), the Hospital Anxiety and Depression Scale, and the Female Sexual Function Index or International Index of Erectile Function. When applicable, additional analyses of the symptom outcomes may include evaluation of secondary response rates defined by specific changes in symptoms. Associations between changes from baseline in secondary outcomes and GRA will be used to supplement the primary endpoint analysis, and to evaluate the validity of the symptom scales for assessing change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leroy M. Nyberg, Jr., Ph.D, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Loyola University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20303115 | Result | Foster HE Jr, Hanno PM, Nickel JC, Payne CK, Mayer RD, Burks DA, Yang CC, Chai TC, Kreder KJ, Peters KM, Lukacz ES, FitzGerald MP, Cen L, Landis JR, Propert KJ, Yang W, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Effect of amitriptyline on symptoms in treatment naive patients with interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1853-8. doi: 10.1016/j.juro.2009.12.106. Epub 2010 Mar 29. | |
| 32734597 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 - Active Comparator | Amitryptiline, increased during a 6-week period from 10 mg up to 75 mg, taken once daily. Amitriptyline: Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Other | Placebo will be dosed exactly as active arm. |
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| Baseline and 12 Weeks |
| Change in Urinary Symptoms Measures | The O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices, and the University of Wisconsin Interstitial Cystitis Symptom Inventory The IC Symptom Index is a 4-question survey w/ a severity scale from min.0(not at all) to max.5(always). The IC Problem Index is a 4-question survey with a severity scale ranging from min.0 (no problem) to max.4 (big problem). Higher subscale responses for each index indicate more severe symptoms. A sub-set of the University of Wisconsin Symptom Survey is designated as the Interstitial Cystitis Symptom Inventory w/ questions ranging from 0(not at all) to 6(a lot). Pts. reported symptoms the day of assessment. Scores ranged from 0 to 42. A higher score indicates more severe symptoms. Symptoms include: bladder pain; bladder discomfort; getting up at night to go to the bathroom; going to the bathroom frequently during the day; urgency to urinate; difficulty sleeping because of bladder problems; and burning sensation in the bladder. | Baseline and 12 weeks |
| Adherence to Study Drug and Urinary Educational/Behavioral Program (EBMP Educational/Behavioral Modification Program) | Adherence to protocol treatment, to study drug and EBMP, at 6 weeks was assessed in 4 categories of 1) symptom management, 2) fluid management, 3) diet modification and 4) bladder training. For each of these EBMP categories adherence was defined as the overall percentage of participants who reported adhering to each component of the EBMP at each telephone contact or clinic visit. Subjects were classified into 3 groups based on the maximum dose obtained at 6 and 12 weeks as shown in the Outcome Measure Data Table below. | 12 weeks |
| Change in Nighttime Voiding From Baseline to 12 Weeks | Baseline nighttime [sleep period] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: "Did this void occur during your intended sleep period?" Responses: 1=Yes, 0=No. The sum was totaled for "Yes" entries in response to this question. | Baseline and 12 weeks |
| Maywood |
| Illinois |
| 60153 |
| United States |
| University of Iowa Hospitals and Clinic | Iowa City | Iowa | 52242 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Queen's University | Kingston | Ontario | K7L 2Y7 | Canada |
| Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
| FG001 | 2 - Placebo Comparator | Placebo will be dosed exactly as the active arm and taken once daily. Placebo: Placebo will be dosed exactly as active arm. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 - Active Comparator | Amitryptiline, increased during a 6-week period from 10 mg up to 75 mg, taken once daily. Amitriptyline: Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet. |
| BG001 | 2 - Placebo Comparator | Placebo will be dosed exactly as the active arm and taken once daily. Placebo: Placebo will be dosed exactly as active arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants ever diagnosed with IC/PBS | Count of Participants | Participants |
| ||||||||||||||||
| Pain score | Pain at Baseline was assessed on a 0 to 10-point Likert scale in response to the following question: "Think about the pain/discomfort associated with your bladder, prostate, and/or pelvic region. On average, how would you rate this pain/discomfort during the past 4 weeks?" Results ranged from 0 (No pain/discomfort) to 10 (Most severe pain I can imagine). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Urgency score | Urgency at Baseline was assessed on a 0 to 10-point Likert scale in response to the following question: "Urgency is defined as the urge or pressure to urinate. On average, how would you rate the urgency that you have felt during the past 4 weeks?" Results ranged from 0 (No urgency) to 10 (Most severe urgency I can imagine). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Frequency score | Frequency at Baseline was assessed on a 0 to 10-point Likert scale in response to the following question: "Think about your frequency of urination compared to what you consider to be normal. On average, how would you rate your frequency of urination during the past 4 weeks?" Results ranged from 0 (Totally normal) to 10 (Most severe frequency I can imagine). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 24-Hr voiding frequency | Baseline 24-hr. voiding frequency was collected on a 24-hr. void diary on the VOID form. The total number of voids in the 24-hr. period were collected along with the times of when voids occurred. The mean was calculated by the total number of voids reported by the 135 and 136 participants in each cohort. | Mean | Standard Deviation | Voiding events |
| ||||||||||||||
| Nighttime voiding frequency | Baseline nighttime [sleep period] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: "Did this void occur during your intended sleep period?" Responses: 1=Yes, 0=No. The sum was totaled for "Yes" entries in response to this question. | Mean | Standard Deviation | Voiding events |
| ||||||||||||||
| Interstitial Cystitis Symptom Index | Interstitial Cystitis Symptom Index is a 4-question survey w/ a severity scale from min.0(not at all) to max.5(always). Higher subscale responses indicate higher symptom severity. Tot. score per Pt. is the sum ranging from 0 (min) - 20 (max). Mean is reported per cohort. Pts. reported symptoms "During the past month"
| Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Interstitial Cystitis Problem Index | Interstitial Cystitis Problem Index is a 4-question survey with a severity scale ranging from minimum 0 (no problem) to maximum 4 (big problem). Higher subscale responses indicate more severe symptoms. The total score is the sum for each participant ranges from 0 (minimum)-16 (maximum). The mean score is reported per cohort. Pts. reported symptoms "During the past month..."
| Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| University of Wisconsin Symptom Inventory | A sub-set of the University of Wisconsin Symptom Survey is designated as the Interstitial Cystitis Symptom Inventory w/ questions ranging from 0(not at all) to 6(a lot). Pts. reported symptoms the day of assessment. The Inventory characterized the IC patient w/ total scores ranging from 0 to 42. A higher score indicates more severe symptoms. Symptoms include: bladder pain; bladder discomfort; getting up at night to go to the bathroom; going to the bathroom frequently during the day; urgency to urinate; difficulty sleeping because of bladder problems; and burning sensation in the bladder. | Mean | Standard Deviation | units on a scale |
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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 | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Response Assessment (GRA) | The primary efficacy analysis was based on intent to treat, comparing the proportion of responders between treatment arms on a patient reported GRA recorded at 12 weeks or study withdrawal. The 7-point GRA queried, "As compared to when you started the current study, how would you rate your overall symptoms now?" The 7 response options were markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. Participants who indicated that they were markedly or moderately improved were considered responders. Subjects who withdrew from the study for any reason and did not provide data on the primary outcome were considered treatment failures, and were included in the denominator for calculation of response rates. | Posted | Count of Participants | Participants | 12 Weeks |
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| Secondary | Changes in Quality of Life Measures From Baseline to 12 Weeks | A number of secondary outcomes [as detailed in the Baseline Measures section] were assessed throughout the study. These outcomes include pain, urgency and frequency on 0 to 10-point Likert scales, a 24-hour voiding diary, the Health Status Questionnaire for Quality of Life (SF-36), the Hospital Anxiety and Depression Scale, and the Female Sexual Function Index or International Index of Erectile Function. When applicable, additional analyses of the symptom outcomes may include evaluation of secondary response rates defined by specific changes in symptoms. Associations between changes from baseline in secondary outcomes and GRA will be used to supplement the primary endpoint analysis, and to evaluate the validity of the symptom scales for assessing change. | Posted | Mean | Standard Deviation | Change in score baseline to 12 weeks | Baseline and 12 Weeks |
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| Secondary | Change in Urinary Symptoms Measures | The O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices, and the University of Wisconsin Interstitial Cystitis Symptom Inventory The IC Symptom Index is a 4-question survey w/ a severity scale from min.0(not at all) to max.5(always). The IC Problem Index is a 4-question survey with a severity scale ranging from min.0 (no problem) to max.4 (big problem). Higher subscale responses for each index indicate more severe symptoms. A sub-set of the University of Wisconsin Symptom Survey is designated as the Interstitial Cystitis Symptom Inventory w/ questions ranging from 0(not at all) to 6(a lot). Pts. reported symptoms the day of assessment. Scores ranged from 0 to 42. A higher score indicates more severe symptoms. Symptoms include: bladder pain; bladder discomfort; getting up at night to go to the bathroom; going to the bathroom frequently during the day; urgency to urinate; difficulty sleeping because of bladder problems; and burning sensation in the bladder. | Change between the Baseline and 12-week time points is reported for each measure. | Posted | Mean | Standard Deviation | Change in score baseline to 12 weeks | Baseline and 12 weeks |
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| Secondary | Adherence to Study Drug and Urinary Educational/Behavioral Program (EBMP Educational/Behavioral Modification Program) | Adherence to protocol treatment, to study drug and EBMP, at 6 weeks was assessed in 4 categories of 1) symptom management, 2) fluid management, 3) diet modification and 4) bladder training. For each of these EBMP categories adherence was defined as the overall percentage of participants who reported adhering to each component of the EBMP at each telephone contact or clinic visit. Subjects were classified into 3 groups based on the maximum dose obtained at 6 and 12 weeks as shown in the Outcome Measure Data Table below. | Consistent with intent to treat analytic strategies participants who did not provide data at 12 weeks, including 24 (18%) on amitriptyline and 17 (13%) on placebo, were considered treatment non-responders. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Change in Nighttime Voiding From Baseline to 12 Weeks | Baseline nighttime [sleep period] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: "Did this void occur during your intended sleep period?" Responses: 1=Yes, 0=No. The sum was totaled for "Yes" entries in response to this question. | Changes in nighttime voids from baseline to 12 weeks were reported by treatment arm for those with available data at those points. Nighttime [sleep period] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: "Did this void occur during your intended sleep period?" Responses: 1=Yes, 0=No. The sum was totaled for "Yes" entries in response to this question. | Posted | Mean | Standard Deviation | Change in voiding events | Baseline and 12 weeks |
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12 weeks
Final Adverse Event reporting included all adverse events by type, regardless of their relationship to study drug.
Patients are counted once in each category and included in the column relating to their worst toxicity grade. Patients may have had events in more than one body system category. An adverse event is not counted if the same event is observed at baseline with an equal or greater toxicity grade.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 - Amitriptyline | Amitryptiline, increased during a 6-week period from 10 mg up to 75 mg, taken once daily for a total of 12 weeks. Amitriptyline: Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet. | 0 | 135 | 2 | 135 | 119 | 135 |
| EG001 | 2 - Placebo | Placebo will be dosed exactly as the active arm and taken once daily for a total of 12 weeks. Placebo: Placebo will be dosed exactly as active arm. | 0 | 136 | 3 | 136 | 98 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 6.0 | Systematic Assessment |
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| Mass found on chest x-ray | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
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| Sudden onset of nausea, abdominal pain, SOB, subscapular pain w/left arm radiation | Cardiac disorders | MedDRA 6.0 | Systematic Assessment |
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| Diagnosed with prostate cancer | Renal and urinary disorders | MedDRA 6.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatology/skin | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Gastrointestinal | General disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Constitutional symptoms | General disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Infection, fever | Infections and infestations | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Musculokeletal | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Neurological | Ear and labyrinth disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Ocular, visual | Eye disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Pain | Nervous system disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Genitourinary | Renal and urinary disorders | MedDRA 6.0 | Systematic Assessment | All AEs reported by type, regardless of relationship to study drug. Pts. counted once per category according to worst toxicity grade. An AE is not counted if same event is observed at baseline w/ equal or greater toxicity grade. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Richard Landis, PhD | University of Pennsylvania | 215-5734922 | hultman@upenn.edu |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003556 | Cystitis |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 |
| 2 - Placebo Comparator |
Placebo will be dosed exactly as the active arm and taken once daily. Placebo: Placebo will be dosed exactly as active arm. |
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