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NCT00150280 Clinical Trial

Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery

Pain, Postoperative Clinical Trial

Official title:
A Prospective, Randomized, Double-Blind, Double-Dummy, Multi-Center Study Comparing Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150280
Other study ID # A3191086
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date July 2005

Study information
Verified date March 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Undergone uncomplicated orthopedic surgery or abdominal gynecological surgery under epidural anesthesia - Baseline pain intensity of more than 45 mm as measured by VAS and a severity of pain graded as moderate or severe on the categorical pain intensity scale Exclusion Criteria: - A previous history of intolerance or hypersensitivity to any NSAIDs, cyclooxygenase inhibitor, sulfonamides, or any analgesic, or to drugs with similar chemical structures

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• celecoxib and ibuprofen SR

Locations
Country Name City State
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary To validate the analgesic efficacy of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery
Secondary To validate safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery
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