Phase 3
N=89
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Nocturnal Enuresis
Bottom Line
View on ClinicalTrials.gov: NCT01078753 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Change in the Number of Wet Nights Between Baseline and Treatment Period II — 3.264; 1.451 wet nights — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desmopressin (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Wet Nights Between Baseline and Treatment Period II |
3.264; 1.451 | 0.009 sig |
| SECONDARY Change in Number of Wet Nights Between Baseline and Treatment Period I |
2.946; 1.317 | 0.018 sig |
| SECONDARY Change in Number of Wet Nights Between Treatment Periods I and II |
0.318; 0.135 | 0.752 |
Summary
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
Eligibility Criteria
Inclusion Criteria
- Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
- Age 6 or above but under 16 regardless of gender
- Out-patient
- Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
- Deemed healthy by the investigator
- Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
- Consent from the pediatric patient's legally acceptable representative
- Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
- Show no possibility of being a nursing mother or pregnant, or becoming pregnant
- If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment
Exclusion Criteria
- Suffer from enuresis with an underlying disease
- Participated in another clinical trial within six months preceding consent
- Used an intranasal Desmopressin in the past
- Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
- Have an anomaly or a disease that may affect the oral absorption of drug products
- Hard to get cooperation from subject by school refusal, punishment or bullying
- Deemed by the investigator to be inappropriate to participate in this trial
- Unable to be placed on water-intake restriction starting from two hours before bedtime
- Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Data sourced from ClinicalTrials.gov (NCT01078753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.