ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00894790
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 7, 2009
Results First Posted : February 25, 2011
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Pfizer

March 27, 2009
May 7, 2009
January 28, 2011
February 25, 2011
March 1, 2011
November 2009
January 2010   (Final data collection date for primary outcome measure)
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain [ Time Frame: Baseline, Day 7 ]
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
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 ]
Complete list of historical versions of study NCT00894790 on ClinicalTrials.gov Archive Site
  • Change From Baseline on VAS-pain at Day 3 and Day 14 [ Time Frame: Baseline, Days 3, 14 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
  • Change from Baseline on VAS-pain [ Time Frame: Days 3, 14 ]
  • Responder rates [ Time Frame: Days 7, 14 ]
  • Change from baseline of Patient Global Assessment of Cervical Injury [ Time Frame: Days 7, 14 ]
  • Change From Baseline on Physician's Global Assessment of Cervical Injury [ Time Frame: Days 7, 14 ]
  • Change from Baseline of Subject's responses to (m-BPI-sf): pain severity score and pain interference score. [ Time Frame: Days 7, 14 ]
  • Change from Baseline of Subject's GI symptoms as assessed by the GI Symptom Questionnaire [ Time Frame: Days 7, 14 ]
Not Provided
Not Provided
 
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
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
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
  • Drug: Celecoxib
    celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
  • Drug: oral Diclofenac
    diclofenac 75 mg tablet BID (twice a day)
  • Experimental: 1
    Intervention: Drug: Celecoxib
  • Active Comparator: 2
    Intervention: Drug: oral Diclofenac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
150
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00894790
A3191352
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP