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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen; pseudoephedrine HCl | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32364251 | Derived | 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. |
| Label | URL |
|---|---|
| A Study to Determine if Ibuprofen in Combination with Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting | View source |
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| ID | Term |
|---|---|
| D004775 | Enuresis |
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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