Desmopressin Response in the Young (DRY)
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00230594
First received: September 28, 2005
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Nocturnal Enuresis |
Drug: desmopressin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Desmopressin Response in the Young: A Double-blind, Randomised, Placebo-controlled, Dose-titration Study With Three Different Doses (120 Mcg, 240 Mcg and 360 Mcg) of Desmopressin Administered as a New Melt Tablet in Children and Adolescents With Primary Nocturnal Enuresis (PNE). |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of reducing the number of wet nights in children and adolescents with primary nocturnal enuresis. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of percentage baseline reduction in the number of wet nights. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
- To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of the proportion of full, partial and non-responders. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: No ]
- To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested. [ Time Frame: 14 days of screening plus 54 days of treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 132 |
| Study Start Date: | July 2004 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
desmopressin
|
Drug: desmopressin
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
Other Name: DDAVP
|
|
Placebo Comparator: 2
placebo
|
Drug: placebo
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
|
Detailed Description:
Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease. Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for V2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder capacity.
A melt tablet formulation offers benefits compared to regular tablets and nasal spray. Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.
Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.
- A minimum of 3 wet nights per week in the 2-week screening period without treatment.
Exclusion Criteria:
- Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.
- Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.
- Usage of any experimental drug or device during 30 days before study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230594
Locations
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| The Male Health Centres | |
| Barrie, Ontario, Canada, L4M 7G1 | |
| Cambridge Family Medical Centre | |
| Cambridge, Ontario, Canada, N3C 1Z3 | |
| Private Clinic | |
| London, Ontario, Canada | |
| Quest Clinical Trials Inc. | |
| Markham, Ontario, Canada, L6B 1A1 | |
| Private Clinic | |
| North Bay, Ontario, Canada, P1B 4Z2 | |
| The Male Health Centres | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| Markham Place Med Centre | |
| Thornhill, Ontario, Canada, L3T 4X1 | |
| The Kids Clinic | |
| Whitby, Ontario, Canada, L1N 8M7 | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Clinical Development Support, Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00230594 History of Changes |
| Other Study ID Numbers: | FE992026, CLN 10.3.26 |
| Study First Received: | September 28, 2005 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Enuresis Nocturnal Enuresis Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Deamino Arginine Vasopressin |
Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013