Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00150280
Collaborator
(none)
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Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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
Study Start Date
:
Oct 1, 2004
Study Completion Date
:
Jul 1, 2005
Outcome Measures
Primary Outcome Measures
- To validate the analgesic efficacy of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery []
Secondary Outcome Measures
- To validate safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Shenyang | Liaoning | China | 110001 |
| 2 | Pfizer Investigational Site | Beijing | China | 100020 | |
| 3 | Pfizer Investigational Site | Beijing | China | 100034 | |
| 4 | Pfizer Investigational Site | Beijing | China | 100083 | |
| 5 | Pfizer Investigational Site | Shanghai | China | 200025 | |
| 6 | Pfizer Investigational Site | Shanghai | China | 200032 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00150280
Other Study ID Numbers:
- A3191086
First Posted:
Sep 8, 2005
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021