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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00894790

Purpose

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

Condition	Intervention	Phase
Pain	Drug: Celecoxib Drug: oral Diclofenac	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline on VAS-pain [ Time Frame: Days 3, 14 ] [ Designated as safety issue: No ]
Responder rates [ Time Frame: Days 7, 14 ] [ Designated as safety issue: No ]
Change from baseline of Patient Global Assessment of Cervical Injury [ Time Frame: Days 7, 14 ] [ Designated as safety issue: No ]
Change from Baseline on Physician's Global Assessment of Cervical Injury [ Time Frame: Days 7, 14 ] [ Designated as safety issue: No ]
Change from Baseline of Subject's responses to (m-BPI-sf): pain severity score and pain interference score. [ Time Frame: Days 7, 14 ] [ Designated as safety issue: No ]
Change from Baseline of Subject's GI symptoms as assessed by the GI Symptom Questionnaire [ Time Frame: Days 7, 14 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Celecoxib celecoxib 200 mg BID with a loading dose of 400mg
2: Active Comparator	Drug: oral Diclofenac diclofenac 75 mg tablet BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894790

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Mexico, D.F.
Pfizer Investigational Site	Recruiting
Mexico, D.F., Mexico, 04500
Pfizer Investigational Site	Recruiting
Mexico, D.F., Mexico, 11510
Mexico, Nuevo Leon
Pfizer Investigational Site	Not yet recruiting
Monterrey, Nuevo Leon, Mexico

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191352
Study First Received:	March 27, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00894790 History of Changes
Health Authority:	Mexico: Ministry of Health

Keywords provided by Pfizer:

Treatment of the acute pain due to cervical sprain; Celecoxib; NSAID; Diclofenac;

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010