Skip to main content

91-113 - Efficacy and pharmacokinetic/pharmacodynamic profile of ibuprofen chewable tablets versus ibuprofen suspension in febrile children. CSR 167S. Protocol 91-113, Unpublished Report 293A and Unpublished Report 1475.

Efficacy and pharmacokinetic/pharmacodynamic profile of ibuprofen chewable tablets versus ibuprofen suspension in febrile children. CSR 167S. Protocol 91-113, Unpublished Report 293A and Unpublished Report 1475.


Primary Citation

Not Available


Data Specification

Not Available


Annotated CRF

Not Available

Data Request Dashboard

Operations

No data requests found. Click here to generate a new one.

Product Info

Generic Name
Ibuprofen
Product Name
PediaProfen
Therapeutic Area
Pain, Inflammation, Fever
Enrollment
85
% Female
48.2%
% White
N/A
Product Class
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Sponsor Protocol Number
91-113
Data Holder
Johnson & Johnson
Condition Studied
Fever
Mean/Median Age (Years)
N/A

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Protocol with Amendments
Study Phase 
3
Additional Information: 

Only a limited collected dataset can be made available.

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.