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ibuprofen; pseudoephedrine

Phase 2

Enuresis | Small molecule | Other |Johnson & Johnson|Trials Updated: Jun 29, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment318

FDA Designations

No designations recorded

ibuprofen; pseudoephedrine clinical trials

ibuprofen; pseudoephedrine · 1 trial · 1 indication

Phase 2 1
NCT00240812A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime BedwettingEnuresis
COMPLETED318 Analytics
PHASE2COMPLETED
A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
EnuresisUnlock trial analytics

Study Endpoints

Primary Endpoints

The mean reduction in wet nights from the 14-day baseline period to the 14-day treatment period.

Secondary Endpoints

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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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ibuprofen; pseudoephedrine HClDRUG -
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Eligibility Criteria

Age Range6 Years to 11 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 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 revie...

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Frequently asked questions about ibuprofen; pseudoephedrine

What is ibuprofen; pseudoephedrine used for?

Ibuprofen; pseudoephedrine is being studied for the treatment of enuresis, commonly known as nighttime bedwetting. It is a small molecule combination drug developed by Johnson & Johnson. The research focuses on whether the combination is more effective than either drug alone in managing this condition.

Who is developing ibuprofen; pseudoephedrine?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of the ibuprofen; pseudoephedrine combination. The company sponsored the clinical research evaluating this fixed-dose combination for enuresis.

What phase is ibuprofen; pseudoephedrine in?

Ibuprofen; pseudoephedrine is in Phase 2 clinical development. The only listed trial for this combination is a completed Phase 2 study. It is an investigational product and has not been approved by the FDA for the treatment of enuresis.

What clinical trials is ibuprofen; pseudoephedrine in?

Ibuprofen; pseudoephedrine has been evaluated in one completed clinical trial, NCT00240812. The study was titled "A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting." It enrolled 318 participants aged 6 years and older.