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Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident

Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Celecoxib (Drug); oral Diclofenac (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident

Clinical Details

Official title: A Phase IV Open Label Randomized Multicenter Comparative Study Of Celecoxib Efficacy And Safety Versus Standard Doses Of Oral Diclofenac In Acute Pain Due To Cervical Sprain Related To Motor Vehicle Accident

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primary efficacy endpoint is the change from Baseline at Day 7 of subject' assessment of cervical pain due to cervical sprain using a visual analogue scale

Secondary outcome:

Change from Baseline on VAS-pain

Responder rates

Change from baseline of Patient Global Assessment of Cervical Injury

Change from Baseline on Physician's Global Assessment of Cervical Injury

Change from Baseline of Subject's responses to (m-BPI-sf): pain severity score and pain interference score.

Change from Baseline of Subject's GI symptoms as assessed by the GI Symptom Questionnaire

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain

Exclusion Criteria:

- Recent Cervical Sprains Or Other Cervical Conditions

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Mexico, D.F. 04500, Mexico

Pfizer Investigational Site, Mexico, D.F. 11510, Mexico

Pfizer Investigational Site, Monterrey, Nuevo Leon C.P.64620, Mexico

Pfizer Investigational Site, Monterrey, Nuevo Leon, Mexico

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2009
Ending date: September 2010
Last updated: October 11, 2009

Page last updated: October 19, 2009

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