Primary Nocturnal EnuresisPhase 4PALATNCT00209261
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
A Phase 4 study testing MINIRIN Oral Lyophilisate and Minirin tablet in people with Primary Nocturnal Enuresis, run by Ferring Pharmaceuticals at 1 site in France.
Trial summary
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Nocturnal Enuresis
- What is being tested?
- MINIRIN Oral Lyophilisate and Minirin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Sep 2005
- 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
Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades
Paris
About this study
Official title: A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
Read the detailed description
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
- Conditions
- Primary Nocturnal Enuresis
- Being tested
- MINIRIN Oral Lyophilisate, Minirin tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIRIN Oral LyophilisateDrug
Minirin tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: MINIRIN Oral Lyophilisate |
| 2 | Active comparator | Not described Receives: Drug: Minirin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.
Measured: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
Secondary outcomes (6)
Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.
Measured: 3 weeks
The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.
Measured: 3 weeks
Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
Measured: 3 weeks
Safety comparison between the 2 formulations.
Measured: 6 weeks
Comparison of compliance between the 2 formulations.
Measured: 6 weeks
The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.
Measured: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2005
- Study completionSep 2005
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 221 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
- NCT00209261
- Sponsor's protocol ID
- FE992026 CS022
- Acronym
- PALAT
- Status last verified
- May 2011
- First submitted
- 13 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.
PubMed 40728007Caldwell 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 32364251Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.
PubMed 23677249
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
- A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)
- ClinicalTrials.gov ID
- NCT00209261
- Acronym / sponsor ID
- PALAT / FE992026 CS022
- Conditions
- Primary Nocturnal Enuresis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 21 Sep 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 preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
Detailed description
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MINIRIN Oral Lyophilisate |
| 2 | Active comparator | Drug: Minirin tablet |
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 |
|---|---|---|
| MINIRIN Oral Lyophilisate | Drug | 1 |
| Minirin tablet | Drug | 2 |
Primary outcome
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period.
Time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
6 secondary outcomes
Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.
Time frame: 3 weeks
The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.
Time frame: 3 weeks
Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
Time frame: 3 weeks
Safety comparison between the 2 formulations.
Time frame: 6 weeks
Comparison of compliance between the 2 formulations.
Time frame: 6 weeks
The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.
Time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.
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 40728007Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.
- 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.
- Derived from this study: PubMed 23677249Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.
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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 MINIRIN Oral Lyophilisate and Minirin tablet in people with Primary 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?
The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period. (time frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.). 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 NCT00209261, 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.