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 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Celecoxib (Drug); oral Diclofenac (Drug)
Phase: Phase 4
Status: 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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-painResponder 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; Recruiting
Pfizer Investigational Site, Mexico, D.f. 11510, Mexico; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2009
Last updated: September 8, 2010
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