Trial · Interventional

CompletedPhase 3Results postedRegistry data

Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

Short name COMFORT

NCTNCT01223937Other idFE992026 CS40

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 268 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Canada
Start: Nov 2010
Primary completion: Nov 2011
Completion: Nov 2011
First posted: 19 Oct 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

201020112012

Ph 3
COMFORT
NCT01223937
Nov 2010 to Nov 2011

Registry summary

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

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.

Interventions

DesmopressinDrug
PlaceboDrug

Arms2

Experimental
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.
Placebo comparator
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

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 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 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.
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 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 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.

Secondary outcomes(7)

Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Time frame · Day 1 (Baseline), Month 3
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 (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.
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.
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 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.
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.
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.
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame · Day 1 up to 3 months
Registry description
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.
Minimum Post-Treatment Serum Sodium Levels
Time frame · Day 1 up to 3 months
Registry description
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.

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 treatment period)

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

Group	Value (nocturnal voids)	Spread
Placebo	-1	0.94
Desmopressin 25 μg	-1.21	0.957

Primary outcomeNumber· 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

Group	Value (probability)
Placebo	0.64
Desmopressin 25 μg	0.76

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

Group	Value (nocturnal voids)	Spread
Placebo	-1.38	1.13
Desmopressin 25 μg	-1.69	0.978

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

Group	Value (probability)
Placebo	0.69
Desmopressin 25 μg	0.79

Secondary outcomeMean· Day 1 (Baseline), Month 3

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

Group	Value (minutes)	Spread
Placebo	115	139
Desmopressin 25 μg	168	138

Secondary outcomeMean· Day 1 (Baseline), Month 3

Change From Baseline in Nocturnal Urine Volume at Month 3

Group	Value (mL)	Spread
Placebo	-151	262
Desmopressin 25 μg	-242	283

Secondary outcomeMean· Day 1 (Baseline), Month 3

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

Group	Value (mL)	Spread
Placebo	-152	497
Desmopressin 25 μg	-255	522

Secondary outcomeNumber· Day 1 up to 3 months

Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)

Group	Value (participants)
Placebo	57
Desmopressin 25 μg	60

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants 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
Desmopressin 25 μgParticipants 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

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

8 results

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.

Sand et al. 2013The Journal of urologycited by 57

PMID 23454404DOI 10.1016/j.juro.2013.02.037PUB-23454404

Full text at the publisher8 results

Publisher page See results (8)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2017

Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia.

Juul et al. 2017BJU internationalcited by 33

PMID 27862898DOI 10.1111/bju.13718PUB-27862898

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
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 * Female sex 18 years of age or older * At least 2 voids every night in a consecutive 3-day period during the screening period Exclusion Criteria: 1. 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) 2. Interstitial cystitis 3. Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention 4. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours) 5. Central or nephrogenic diabetes insipidus 6. Syndrome of inappropriate anti-diuretic hormone secretion 7. Current or a history of urologic malignancies e.g. bladder cancer 8. Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms 9. Neurogenic detrusor activity (detrusor overactivity). 10. Suspicion or evidence of cardiac failure 11. Uncontrolled hypertension 12. Uncontrolled diabetes mellitus 13. Hyponatraemia: Serum sodium level must be within normal limits 14. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min 15. 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 16. History of obstructive sleep apnea 17. Previous desmopressin treatment for nocturia 18. Treatment with another investigational product within 3 months prior to screening 19. Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug 20. 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 21. Known alcohol or substance abuse 22. Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers 23. 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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