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ibuprofen; pseudoephedrine

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as ibuprofen; pseudoephedrine HCl

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

Clinical trial landscape

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
Enuresis
NCT00240812318
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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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