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Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
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
1 other identifier
interventional
8
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pain
Started Nov 2009
Shorter than P25 for phase_4 pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
February 25, 2011
CompletedFebruary 2, 2021
January 1, 2021
2 months
March 27, 2009
January 28, 2011
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
Baseline, Day 7
Secondary Outcomes (8)
Change From Baseline on VAS-pain at Day 3 and Day 14
Baseline, Days 3, 14
Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
Baseline, Days 7, 14
Change From Baseline in Patient Global Assessment of Cervical Injury
Baseline, Days 7, 14
Change From Baseline on Physician's Global Assessment of Cervical Injury
Baseline, Days 7, 14
Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
Baseline, Days 7, 14
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain
You may not qualify if:
- Recent Cervical Sprains Or Other Cervical Conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pfizer Investigational Site
México, D.F., 04500, Mexico
Pfizer Investigational Site
México, D.F., 11510, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2009
First Posted
May 7, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 2, 2021
Results First Posted
February 25, 2011
Record last verified: 2021-01