Nocturnal EnuresisPhase 4DRIPNCT00245479
A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
A Phase 4 study testing Primary nocturnal enuresis in people with Nocturnal Enuresis, run by Ferring Pharmaceuticals at 1 site in France.
Trial summary
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment. To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. To evaluate the proportion of patients achieving dryness. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Primary nocturnal enuresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2002to Nov 2006
- Phase
- Phase 4
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children suffering from primary nocturnal enuresis with no organic pathology.
- Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
- Children with a minimum of 6 wet nights in 2 weeks.
Who cannot join
- Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
- Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
- Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
- Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Foundation Hospital Saint Joseph, 185, rue Raymond Losserand
Paris, 75674
About this study
Official title: An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
Read the detailed description
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
- Conditions
- Nocturnal Enuresis
- Being tested
- Primary nocturnal enuresis
- Keywords
- Primary nocturnal enuresis
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary nocturnal enuresisDrug
Desmopressin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Primary nocturnal enuresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment
Secondary outcomes (3)
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness.
To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startApr 2002
- Primary completionSep 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 802 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
- NCT00245479
- Sponsor's protocol ID
- FE992026 CS002
- Acronym
- DRIP
- Status last verified
- May 2011
- First submitted
- 13 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Herzeele C, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Predictive parameters of response to desmopressin in primary nocturnal enuresis. J Pediatr Urol. 2015 Aug;11(4):200.e1-8. doi: 10.1016/j.jpurol.2015.03.007. Epub 2015 May 21.
PubMed 26059526Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Safety profile of desmopressin tablet for enuresis in a prospective study. Adv Ther. 2014 Dec;31(12):1306-16. doi: 10.1007/s12325-014-0173-1. Epub 2014 Dec 12.
PubMed 25504157Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract. 2009 Jan;63(1):35-45. doi: 10.1111/j.1742-1241.2008.01956.x.
PubMed 19125991
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
- An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT00245479
- Acronym / sponsor ID
- DRIP / FE992026 CS002
- Conditions
- Nocturnal Enuresis
- Keywords
- Primary nocturnal enuresis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 28 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.
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
Detailed description
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Primary nocturnal enuresis |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children suffering from primary nocturnal enuresis with no organic pathology.
- Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
- Children with a minimum of 6 wet nights in 2 weeks.
Key exclusion criteria (4 listed)
- Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
- Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
- Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
- Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
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 |
|---|---|---|
| Primary nocturnal enuresisDesmopressin | Drug | 1 |
Primary outcome
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment
3 secondary outcomes
To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.
To evaluate the proportion of patients achieving dryness.
To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.
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 26059526Van Herzeele C, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Predictive parameters of response to desmopressin in primary nocturnal enuresis. J Pediatr Urol. 2015 Aug;11(4):200.e1-8. doi: 10.1016/j.jpurol.2015.03.007. Epub 2015 May 21.
- Derived from this study: PubMed 25504157Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Safety profile of desmopressin tablet for enuresis in a prospective study. Adv Ther. 2014 Dec;31(12):1306-16. doi: 10.1007/s12325-014-0173-1. Epub 2014 Dec 12.
- Derived from this study: PubMed 19125991Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract. 2009 Jan;63(1):35-45. doi: 10.1111/j.1742-1241.2008.01956.x.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Primary nocturnal enuresis in people with Nocturnal Enuresis, run by Ferring Pharmaceuticals at 1 site in France.
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 3 inclusion and 4 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 1 site in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months 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 NCT00245479, which also lists 3 linked publications.
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.