A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting

NCT00240812 | Completed Phase 2

• 1 other identifier: CR002497
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Enuresis

Keywords

nocturnal enuresis; bedwetting; ibuprofen

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

ibuprofen; pseudoephedrine HCl DRUG

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Related Publications (1)

• 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.

  PMID: 32364251 DERIVED

Related Links

• A Study to Determine if Ibuprofen in Combination with Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting

MeSH Terms

Conditions

Enuresis; Nocturnal Enuresis

Interventions

Ibuprofen; Pseudoephedrine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Completion: November 1, 2002
• Last Updated: June 29, 2011

Record last verified: 2011-06