EnuresisPhase 2NCT00240812
A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
A Phase 2 study testing ibuprofen; pseudoephedrine HCl in people with Enuresis, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Enuresis
- What is being tested?
- ibuprofen; pseudoephedrine HCl
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Nov 2002
- Phase
- Phase 2
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has nighttime bedwetting
- between the 5th and 95th percentiles for weight based on age and gender
- has a minimum of eight wet nights per 14 days of the baseline period
- healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests.
Who cannot join
- Subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation)
- has had episodes of dryness lasting one month or longer, at any time in the past
- has a medical condition which may be relevant to participation in the study
- has a known sensitivity or allergy to the study medications.
About this study
Official title: A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children
The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.
Read the detailed description
The objective of this double-blind, placebo-controlled, randomized, parallel-group study is to determine whether the effectiveness of ibuprofen in combination with pseudoephedrine HCl is greater than the individual drugs alone and greater than placebo for the treatment of nighttime bedwetting in children. After a screening visit, parents of eligible patients are to record in a diary, the number of urinations and wet and dry nights. Patients then return and those who continue to be eligible are randomized to study medication, which they will take for two weeks. Patients are randomized into four treatment groups, and the dose of treatment medication is determined based on body weight. The four treatment groups are: 12.5 mg of ibuprofen suspension/kg of body weight (200-450 mg of ibuprofen) plus 15 mg or 30 mg of pseudoephedrine HCl, 12.5 mg of ibuprofen suspension / kg of body weight (200 - 450 mg of ibuprofen) plus placebo suspension, or two doses of placebo suspension. The primary efficacy measurement is the mean reduction in wet nights, for the 14-day baseline period to the 14-day treatment period. Safety assessments consist of monitoring adverse events, physical examination and assessment of vital signs. The study hypothesis is that ibuprofen in combination with pseudoephedrine HCl has a greater effect in the treatment of nighttime bedwetting than either ibuprofen or pseudoephedrine HCl alone, and the combination is well tolerated. Treatment medication are an oral suspension, expressed as mg/kg body weight. Patients will receive 1 of 4 treatments for 2 weeks: ibuprofen (12.5 mg/kg of body weight) plus 15 or 30 mg of pseudoephedrine, ibuprofen (12.5 mg/kg of body weight) + placebo, 15 or 30 mg of pseudoephedrine, or placebo
- Conditions
- Enuresis
- Being tested
- ibuprofen; pseudoephedrine HCl
- Keywords
- nocturnal enuresis, bedwetting, ibuprofen
- Medical subject headings
- Enuresis, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen; pseudoephedrine HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.
Secondary outcomes (1)
The proportion of subjects with at least a 50% reduction in wet nights from baseline; the mean number of wet nights during the 14 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 posted18 Oct 2005 (estimated)
- Study completionNov 2002
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240812
- Sponsor's protocol ID
- CR002497
- Status last verified
- Jun 2011
- First submitted
- 14 Oct 2005
- Last updated
- 29 Jun 2011
- Results posted
- 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 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Coadministered Doses of Ibuprofen and Pseudoephedrine HCl and Each Drug Alone in the Treatment of Primary Nocturnal Enuresis in Children
- ClinicalTrials.gov ID
- NCT00240812
- Acronym / sponsor ID
- CR002497
- Conditions
- Enuresis
- Keywords
- nocturnal enuresis, bedwetting, ibuprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study completion
- Nov 2002 (actual)
- First posted
- 18 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 the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.
Detailed description
The objective of this double-blind, placebo-controlled, randomized, parallel-group study is to determine whether the effectiveness of ibuprofen in combination with pseudoephedrine HCl is greater than the individual drugs alone and greater than placebo for the treatment of nighttime bedwetting in children. After a screening visit, parents of eligible patients are to record in a diary, the number of urinations and wet and dry nights. Patients then return and those who continue to be eligible are randomized to study medication, which they will take for two weeks. Patients are randomized into four treatment groups, and the dose of treatment medication is determined based on body weight. The four treatment groups are: 12.5 mg of ibuprofen suspension/kg of body weight (200-450 mg of ibuprofen) plus 15 mg or 30 mg of pseudoephedrine HCl, 12.5 mg of ibuprofen suspension / kg of body weight (200 - 450 mg of ibuprofen) plus placebo suspension, or two doses of placebo suspension. The primary efficacy measurement is the mean reduction in wet nights, for the 14-day baseline period to the 14-day treatment period. Safety assessments consist of monitoring adverse events, physical examination and assessment of vital signs. The study hypothesis is that ibuprofen in combination with pseudoephedrine HCl has a greater effect in the treatment of nighttime bedwetting than either ibuprofen or pseudoephedrine HCl alone, and the combination is well tolerated. Treatment medication are an oral suspension, expressed as mg/kg body weight. Patients will receive 1 of 4 treatments for 2 weeks: ibuprofen (12.5 mg/kg of body weight) plus 15 or 30 mg of pseudoephedrine, ibuprofen (12.5 mg/kg of body weight) + placebo, 15 or 30 mg of pseudoephedrine, or placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject has nighttime bedwetting
- between the 5th and 95th percentiles for weight based on age and gender
- has a minimum of eight wet nights per 14 days of the baseline period
- healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests.
Key exclusion criteria (4 listed)
- Subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation)
- has had episodes of dryness lasting one month or longer, at any time in the past
- has a medical condition which may be relevant to participation in the study
- has a known sensitivity or allergy to the study medications.
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 |
|---|---|---|
| ibuprofen; pseudoephedrine HCl | Drug | – |
Primary outcome
The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.
1 secondary outcome
The proportion of subjects with at least a 50% reduction in wet nights from baseline; the mean number of wet nights during the 14 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 29 Jun 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.
- A Study to Determine if Ibuprofen in Combination with Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime BedwettingLink provided by the sponsor.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ibuprofen; pseudoephedrine HCl in people with Enuresis, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 4 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.. 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 NCT00240812, 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 29 Jun 2011.