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A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmopressin 25 μg | Experimental | Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. |
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| Placebo | Placebo Comparator | Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period | The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints. | Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period) |
| Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3 | Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints. | Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids at Month 3 | The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of severe daytime voiding dysfunction defined as:
Interstitial cystitis
Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
Central or nephrogenic diabetes insipidus
Syndrome of inappropriate anti-diuretic hormone secretion
Current or a history of urologic malignancies e.g. bladder cancer
Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms
Neurogenic detrusor activity (detrusor overactivity).
Suspicion or evidence of cardiac failure
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Hyponatraemia: Serum sodium level must be within normal limits
Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
History of obstructive sleep apnea
Previous desmopressin treatment for nocturia
Treatment with another investigational product within 3 months prior to screening
Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months' duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test
Known alcohol or substance abuse
Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers
Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the Investigator, would impair participation in the trial
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center Inc. | Huntsville | Alabama | United States | |||
| Radiant Research Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23454404 | Result | Sand PK, Dmochowski RR, Reddy J, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):958-64. doi: 10.1016/j.juro.2013.02.037. Epub 2013 Feb 20. | |
| 27862898 |
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Randomization was stratified by age (<65 years, >= 65 years).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. |
| FG001 | Desmopressin 25 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
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| Day 1 (Baseline), Month 3 |
| Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3 | Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Day 1 (Baseline), Month 3 |
| Change From Baseline in Mean Time to First Nocturnal Void at Month 3 | The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Day 1 (Baseline), Month 3 |
| Change From Baseline in Nocturnal Urine Volume at Month 3 | The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Day 1 (Baseline), Month 3 |
| Change From Baseline in 24-Hour Urine Volume at Month 3 | Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Day 1 (Baseline), Month 3 |
| Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug. | Day 1 up to 3 months |
| Minimum Post-Treatment Serum Sodium Levels | Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. | Day 1 up to 3 months |
| Scottsdale |
| Arkansas |
| United States |
| Family Medical Center | Foothill Ranch | California | United States |
| Axis Clinical Trials | Los Angeles | California | United States |
| Radiant Research Inc. | Santa Rosa | California | United States |
| Downtown Woman's Health Care | Denver | Colorado | United States |
| Front Range Clinical Research | Wheat Ridge | Colorado | United States |
| South Florida Medical Research | Aventura | Florida | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | United States |
| Avail Clinical Research, LLC | DeLand | Florida | United States |
| FPA Clinical Research | Kissimmee | Florida | United States |
| Sunrise Medical Research | Lauderdale Lakes | Florida | United States |
| DMI Research | Pinellas Park | Florida | United States |
| Southeastern Institute | Columbus | Georgia | United States |
| Southeastern Medical Research Institute | Columbus | Georgia | United States |
| Radiant Research Inc. | Chicago | Illinois | United States |
| NorthShore University HealthSystem | Evanston | Illinois | United States |
| Accelovance | Peoria | Illinois | United States |
| Accelovance | South Bend | Indiana | United States |
| FutureCare Studies | Springfield | Massachusetts | United States |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | United States |
| Beyer Research | Paw Paw | Michigan | United States |
| Remedica, LLC | Rochester | Michigan | United States |
| Radiant Research, Inc. | Edina | Minnesota | United States |
| Radiant Research, Inc. | St Louis | Missouri | United States |
| Radiant Research | Las Vegas | Nevada | United States |
| Anderson & Collins Clinical Research Inc | Edison | New Jersey | United States |
| ACCUMED Research Associates | Garden City | New York | United States |
| Center for Urologic Research of WNY, LLC | Williamsville | New York | United States |
| Radiant Research, Inc. | Akron | Ohio | United States |
| Community Research | Cincinnati | Ohio | United States |
| Complete HealthCare for Women | Columbus | Ohio | United States |
| HWC Women's Research Center | Englewood | Ohio | United States |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | United States |
| Philadelphia Clinical Research, LLC | Philadelphia | Pennsylvania | United States |
| Radiant Research, Inc. | Greer | South Carolina | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States |
| Radiant Research Inc. | Dallas | Texas | United States |
| Quality Research, Inc. | San Antonio | Texas | United States |
| Radiant Research, Inc. | San Antonio | Texas | United States |
| Exemplar Research Inc. | Morgantown | West Virginia | United States |
| CanMed Clinical Research Inc. | Victoria | British Columbia | Canada |
| The Male/Female Health Research Center | Barrie | Ontario | Canada |
| Urology Associates/Urologic Medical Research | Kitchener | Ontario | Canada |
| Investigational site | North Bay | Ontario | Canada |
| Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10. |
Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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Demographic data offered from the Full Analysis Set population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. |
| BG001 | Desmopressin 25 μg | Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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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 | Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period | The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints. | Full analysis set (FAS). | Posted | Mean | Standard Deviation | nocturnal voids | Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period) |
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| Primary | Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3 | Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints. | Full analysis set (FAS). | Posted | Number | probability | Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period) |
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| Secondary | Change From Baseline in Mean Number of Nocturnal Voids at Month 3 | The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary. | Posted | Mean | Standard Deviation | nocturnal voids | Day 1 (Baseline), Month 3 |
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| Secondary | Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3 | Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary. | Posted | Number | probability | Day 1 (Baseline), Month 3 |
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| Secondary | Change From Baseline in Mean Time to First Nocturnal Void at Month 3 | The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary. | Posted | Mean | Standard Deviation | minutes | Day 1 (Baseline), Month 3 |
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| Secondary | Change From Baseline in Nocturnal Urine Volume at Month 3 | The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary. | Posted | Mean | Standard Deviation | mL | Day 1 (Baseline), Month 3 |
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| Secondary | Change From Baseline in 24-Hour Urine Volume at Month 3 | Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit. The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. | Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary. | Posted | Mean | Standard Deviation | mL | Day 1 (Baseline), Month 3 |
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| Secondary | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug. | Safety analysis set | Posted | Number | participants | Day 1 up to 3 months |
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| Secondary | Minimum Post-Treatment Serum Sodium Levels | Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time. | Safety analysis set | Posted | Number | participants | Day 1 up to 3 months |
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Day 1 up to 3 months
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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 | Placebo | Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. | 2 | 126 | 14 | 126 | ||
| EG001 | Desmopressin 25 μg | Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. | 0 | 135 | 12 | 135 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Not provided
| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| >=65 years |
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| Male |
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| Black/African American |
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| Asian |
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| Native Hawaiian/other Pacific Islander |
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| Not Hispanic or Latino |
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| Month 2 (n=116, 121) |
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| Month 3 (n=107, 113) |
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| Superiority or Other |
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| Units | Counts |
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| Participants |
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| Participants |
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