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Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

Primary Purpose

Nocturia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Desmopressin
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent prior to performance of any trial-related activity
  • Male sex 18 years of age or older
  • At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.

Exclusion Criteria:

  • Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
  • Interstitial Cystitis
  • Chronic prostatitis/chronic pelvic pain syndrome
  • Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
  • Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
  • Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
  • Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
  • Central or nephrogenic diabetes insipidus.
  • Syndrome of inappropriate anti-diuretic hormone.
  • Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney 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, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
  • 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

Sites / Locations

  • Pinnacle Research Group, LLC
  • Medical Affiliated Research Center, Inc.
  • Radiant Research, Inc.
  • Premiere Pharmaceutical Research
  • Family Medical Center
  • Axis Clinical Trials
  • Radiant Research, Inc.
  • Genitourinary Surgical Consultants
  • Radiant Research, Inc.
  • Front Range Clinical Research, LLC
  • Connecticut Clinical Research Center, LLC
  • South Florida Medical Research
  • Women's Medical Research Group, LLC
  • Avail Clinical Research, LLC
  • FPA Clinical Research
  • Sunrise Medical Research
  • Advanced Pharma CR, LLC
  • DMI Research
  • Pinellas Urology, Inc
  • Midtown Medical Center
  • Advanced Research Institute, Inc.
  • Radiant Research, Inc.
  • Southeastern Medical Research Institute
  • Radiant Research, Inc.
  • Accelovance
  • Accelovance
  • FutureCare Studies, Inc.
  • Bay State Clinical Trials, Inc.
  • Beyer Research
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Radiant Research
  • Anderson & Collins Clinical Research Inc.
  • Urology Center Research Institute
  • AccuMed Research Associates
  • University Urology Associates
  • Radiant Research, Inc.
  • Community Research
  • Complete HealthCare
  • Urologic Consultants of SE PA
  • Penn Urology
  • Hartwell Research Group, LLC
  • Medical University of South Carolina
  • Radiant Research, Inc.
  • Carolina Urologic Research Center
  • ClinSearch, LLC
  • Radiant Research Inc.
  • Quality Research Incorporated
  • Radiant Research, Inc.
  • Wilford Hall Medical Center
  • Exemplar Research Inc.
  • Can-Med Clinical Research, Inc.
  • The Male/ Female Health and Research Centre
  • Urology Associates / Urologic Medical Research
  • Investigational Site
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Desmopressin 50 μg Double-Blind / 100 μg Open-Label

Desmopressin 75 μg Double-Blind / 100 μg Open-Label

Placebo Double-Blind / Desmopressin 100 μg Open-Label

Arm Description

Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.

Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.

Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.

Outcomes

Primary Outcome Measures

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 outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
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 outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.

Secondary Outcome Measures

Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits 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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
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 the case where there was no nocturnal void. The first morning void was not counted as a 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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
Serum sodium levels were monitored at each study visit 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.
Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
Serum sodium levels were monitored at each study visit 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.

Full Information

First Posted
December 15, 2010
Last Updated
September 16, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01262456
Brief Title
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
Official Title
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin 50 μg Double-Blind / 100 μg Open-Label
Arm Type
Experimental
Arm Description
Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Arm Title
Desmopressin 75 μg Double-Blind / 100 μg Open-Label
Arm Type
Experimental
Arm Description
Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Arm Title
Placebo Double-Blind / Desmopressin 100 μg Open-Label
Arm Type
Placebo Comparator
Arm Description
Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period.
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
FE992026, MINIRIN®, Nocturin®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
Description
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 outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
Time Frame
Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Title
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
Description
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 outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
Time Frame
Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Description
Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits 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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Time Frame
Day 1 (Baseline), Month 3
Title
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Description
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Time Frame
Day 1 (Baseline), Month 3
Title
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
Description
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 the case where there was no nocturnal void. The first morning void was not counted as a 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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Time Frame
Day 1 (Baseline), Month 3
Title
Change From Baseline in Nocturnal Urine Volume at Month 3
Description
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Time Frame
Day 1 (Baseline), Month 3
Title
Change From Baseline in 24-Hour Urine Volume at Month 3
Description
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. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Time Frame
Day 1 (Baseline), Month 3
Title
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
Description
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Time Frame
From Day 1 through Month 3 (double-blind period)
Title
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
Description
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Time Frame
Month 1 of open-label period (Month 4 of treatment)
Title
Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
Description
Serum sodium levels were monitored at each study visit 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.
Time Frame
Day 1 through Month 3 (double-blind period)
Title
Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
Description
Serum sodium levels were monitored at each study visit 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.
Time Frame
Month 1 of open-label period (Month 4 of treatment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent prior to performance of any trial-related activity Male sex 18 years of age or older At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary. Exclusion Criteria: Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period) Interstitial Cystitis Chronic prostatitis/chronic pelvic pain syndrome Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours Central or nephrogenic diabetes insipidus. Syndrome of inappropriate anti-diuretic hormone. Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney 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, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Radiant Research, Inc.
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Premiere Pharmaceutical Research
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Family Medical Center
City
Foothill Rance
State/Province
California
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Radiant Research, Inc.
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Front Range Clinical Research, LLC
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Connecticut Clinical Research Center, LLC
City
Middlebury
State/Province
Connecticut
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Women's Medical Research Group, LLC
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
Sunrise Medical Research
City
Lauderdale Lakes
State/Province
Florida
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
Pinellas Urology, Inc
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Midtown Medical Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Trinity
State/Province
Florida
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Southeastern Medical Research Institute
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Radiant Research, Inc.
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Accelovance
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Accelovance
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
FutureCare Studies, Inc.
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Beyer Research
City
Kalmazoo
State/Province
Michigan
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
Country
United States
Facility Name
Radiant Research, Inc.
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Radiant Research
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Anderson & Collins Clinical Research Inc.
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Urology Center Research Institute
City
Englewood
State/Province
New Jersey
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Complete HealthCare
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Urologic Consultants of SE PA
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Penn Urology
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Hartwell Research Group, LLC
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Radiant Research Inc.
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Quality Research Incorporated
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Wilford Hall Medical Center
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Exemplar Research Inc.
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Can-Med Clinical Research, Inc.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
The Male/ Female Health and Research Centre
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Urology Associates / Urologic Medical Research
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site
City
North Bay
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23454402
Citation
Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.
Results Reference
result

Learn more about this trial

Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

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