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

NCT ID: NCT00150280

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-07-31

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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celecoxib and ibuprofen SR

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Shenyang, Liaoning, China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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A3191086

Identifier Type: -

Identifier Source: org_study_id

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