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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01262456 (opens ClinicalTrials.gov in a new tab)Other idFE992026 CS41
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
395 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
Feb 2011
Primary completion
Jan 2012
Completion
Jan 2012
First posted
17 Dec 2010 (estimated)
Last update posted
15 Oct 2015 (estimated)
Conditions
Nocturia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 3

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

    NCT01262456

    Feb 2011 to Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug
  • PlaceboDrug

Arms3

  • Experimental

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

    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.

  • Experimental

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

    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.

  • Placebo comparator

    Placebo Double-Blind / Desmopressin 100 μg Open-Label

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

    Time frame · Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)

    Registry 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.

  2. Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3

    Time frame · Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)

    Registry 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.

Secondary outcomes(9)

  1. Change From Baseline in Mean Number of Nocturnal Voids at Month 3

    Time frame · Day 1 (Baseline), Month 3

    Registry 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).

  2. Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3

    Time frame · Day 1 (Baseline), Month 3

    Registry 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).

  3. Change From Baseline in Mean Time to First Nocturnal Void at Month 3

    Time frame · Day 1 (Baseline), Month 3

    Registry 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).

  4. Change From Baseline in Nocturnal Urine Volume at Month 3

    Time frame · Day 1 (Baseline), Month 3

    Registry 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).

  5. Change From Baseline in 24-Hour Urine Volume at Month 3

    Time frame · Day 1 (Baseline), Month 3

    Registry 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).

  6. Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period

    Time frame · From Day 1 through Month 3 (double-blind period)

    Registry 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.

  7. Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period

    Time frame · Month 1 of open-label period (Month 4 of treatment)

    Registry 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.

  8. Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period

    Time frame · Day 1 through Month 3 (double-blind period)

    Registry 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.

  9. Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period

    Time frame · Month 1 of open-label period (Month 4 of treatment)

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)

Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

GroupValue (nocturnal voids)Spread
Desmopressin 75 μg Double-Blind-1.061.9
Desmopressin 50 μg Double-Blind-0.9730.898
Placebo Double-Blind-0.5911.05
Primary outcomeNumber· Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind 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

GroupValue (probability)
Desmopressin 75 μg Double-Blind0.67
Desmopressin 50 μg Double-Blind0.67
Placebo Double-Blind0.50
Secondary and other outcome results(6)
Secondary outcomeMean· Day 1 (Baseline), Month 3

Change From Baseline in Mean Number of Nocturnal Voids at Month 3

GroupValue (nocturnal voids)Spread
Desmopressin 75 μg Double-Blind-1.371.13
Desmopressin 50 μg Double-Blind-1.251.01
Placebo Double-Blind-0.9841.04
Secondary outcomeNumber· Day 1 (Baseline), Month 3

Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3

GroupValue (probability)
Desmopressin 75 μg Double-Blind0.68
Desmopressin 50 μg Double-Blind0.66
Placebo Double-Blind0.54
Secondary outcomeMean· Day 1 (Baseline), Month 3

Change From Baseline in Mean Time to First Nocturnal Void at Month 3

GroupValue (minutes)Spread
Desmopressin 75 μg Double-Blind117130
Desmopressin 50 μg Double-Blind113119
Placebo Double-Blind71.5108
Secondary outcomeMean· Day 1 (Baseline), Month 3

Change From Baseline in Nocturnal Urine Volume at Month 3

GroupValue (mL)Spread
Desmopressin 75 μg Double-Blind-199274
Desmopressin 50 μg Double-Blind-186263
Placebo Double-Blind-144260
Secondary outcomeMean· Day 1 (Baseline), Month 3

Change From Baseline in 24-Hour Urine Volume at Month 3

GroupValue (mL)Spread
Desmopressin 75 μg Double-Blind-224549
Desmopressin 50 μg Double-Blind-194491
Placebo Double-Blind-197442
Secondary outcomeNumber· From Day 1 through Month 3 (double-blind period)

Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period

GroupValue (participants)
Placebo Double-Blind58
Desmopressin 50 μg Double-Blind46
Desmopressin 75 μg Double-Blind49

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Desmopressin 50 μg Double-BlindParticipants 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.–4 / 1196 / 119
Desmopressin 75 μg Double-BlindParticipants 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.–5 / 1227 / 122
Placebo Double-BlindParticipants 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.–1 / 1435 / 143
Desmopressin 50 μg Double-Blind / 100 μg Open-LabelParticipants 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 were switched to desmopressin 100 μg for 1-month open-label extension period.–0 / 1010 / 101
Desmopressin 75 μg Double-Blind / 100 μg Open-LabelParticipants 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 were switched to desmopressin 100 μg for 1-month open-label extension period.–1 / 1020 / 102
Placebo Double-Blind / Desmopressin 100 μg Open-LabelParticipants 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 were switched to desmopressin 100 μg for 1-month open-label extension period.–2 / 1241 / 124

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

11 results

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.

Weiss et al. 2013The Journal of urologycited by 61

PMID 23454402DOI 10.1016/j.juro.2012.12.112PUB-23454402

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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