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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00240812 |
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.
Condition | Intervention | Phase |
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Enuresis |
Drug: ibuprofen; pseudoephedrine HCl |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 300 |
Estimated Study Completion Date: | November 2002 |
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
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR002497 |
Study First Received: | October 14, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00240812 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bedwetting ibuprofen nocturnal enuresis |
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic Agents Nasal Decongestants Urologic Diseases Nocturnal Enuresis Phenylephrine Mental Disorders Mental Disorders Diagnosed in Childhood Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Pseudoephedrine Ibuprofen |
Urination Disorders Enuresis Cyclooxygenase Inhibitors Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents Behavioral Symptoms Oxymetazoline Analgesics, Non-Narcotic Ephedrine Peripheral Nervous System Agents Antirheumatic Agents Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Nasal Decongestants Urologic Diseases Nocturnal Enuresis Sensory System Agents Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Pseudoephedrine Ibuprofen Elimination Disorders Urination Disorders Enuresis Sympathomimetics Cyclooxygenase Inhibitors Anti-Asthmatic Agents Enzyme Inhibitors Central Nervous System Stimulants Cardiovascular Agents Pharmacologic Actions Behavioral Symptoms Analgesics, Non-Narcotic |