Primary Nocturnal EnuresisPhase 3DRYNCT00230594
Desmopressin Response in the Young
A Phase 3 study testing desmopressin in people with Primary Nocturnal Enuresis, run by Ferring Pharmaceuticals at 9 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Primary Nocturnal Enuresis
- What is being tested?
- desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 9 sitesCanada
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
The Male Health Centres
Barrie, Ontario, L4M 7G1
Cambridge Family Medical Centre
Cambridge, Ontario, N3C 1Z3
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Private Clinic
London, Ontario
Quest Clinical Trials Inc.
Markham, Ontario, L6B 1A1
Private Clinic
North Bay, Ontario, P1B 4Z2
The Male Health Centres
Oakville, Ontario, L6H 3P1
Markham Place Med Centre
Thornhill, Ontario, L3T 4X1
The Kids Clinic
Whitby, Ontario, L1N 8M7
About this study
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).
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.
Read the 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.
- Conditions
- Primary Nocturnal Enuresis
- Being tested
- desmopressin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressinDrug
Also called DDAVP
desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime
placeboDrug
placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | desmopressin Receives: Drug: desmopressin |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days of screening plus 54 days of treatment
Secondary outcomes (3)
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.
Measured: 14 days of screening plus 54 days of treatment
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.
Measured: 14 days of screening plus 54 days of treatment
To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.
Measured: 14 days of screening plus 54 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startJul 2004
- Primary completionJan 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230594
- Sponsor's protocol ID
- FE992026, CLN 10.3.26
- Acronym
- DRY
- Status last verified
- May 2011
- First submitted
- 28 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
PubMed 32364251
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00230594
- Acronym / sponsor ID
- DRY / FE992026, CLN 10.3.26
- Conditions
- Primary Nocturnal Enuresis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: desmopressindesmopressin |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desmopressinAlso: DDAVPdesmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime | Drug | 1 |
| placeboplacebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime | Drug | 2 |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Derived from this study: PubMed 32364251Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing desmopressin in people with Primary Nocturnal Enuresis, run by Ferring Pharmaceuticals at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.