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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00894790
First received: March 27, 2009
Last updated: February 25, 2011
Last verified: February 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
    Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).


Secondary Outcome Measures:
  • Change From Baseline on VAS-pain at Day 3 and Day 14 [ Time Frame: Baseline, Days 3, 14 ] [ Designated as safety issue: No ]
    Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

  • Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates) [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.

  • Change From Baseline in Patient Global Assessment of Cervical Injury [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).

  • Change From Baseline on Physician's Global Assessment of Cervical Injury [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).

  • Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.

  • Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).

  • Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: Yes ]
    Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).

  • Change From Baseline in Participant's Responses to Neck Disability Index (NDI) [ Time Frame: Baseline, Days 7, 14 ] [ Designated as safety issue: No ]
    NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.


Enrollment: 8
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Celecoxib
celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
Active Comparator: 2 Drug: oral Diclofenac
diclofenac 75 mg tablet BID (twice a day)

Detailed Description:

On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.

  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

Locations
Mexico
Pfizer Investigational Site
Mexico, D.f., Mexico, 04500
Pfizer Investigational Site
Mexico, D.f., Mexico, 11510
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894790     History of Changes
Other Study ID Numbers: A3191352
Study First Received: March 27, 2009
Results First Received: January 28, 2011
Last Updated: February 25, 2011
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:
Sprains and Strains
Wounds and Injuries
Diclofenac
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014