Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery
NCT00150280
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- 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
- A previous history of intolerance or hypersensitivity to any NSAIDs, cyclooxygenase
inhibitor, sulfonamides, or any analgesic, or to drugs with similar chemical
structures
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Descriptive Information | ||||
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Brief Title ICMJE | Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery | |||
Official Title ICMJE | 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 | |||
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 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pain, Postoperative | |||
Intervention ICMJE | Drug: celecoxib and ibuprofen SR | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 132 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | July 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00150280 | |||
Other Study ID Numbers ICMJE | A3191086 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |