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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Celecoxib
Drug: oral Diclofenac
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Period Title: Overall Study
Started 4 4
Completed 3 2
Not Completed 1 2
Reason Not Completed
Protocol Violation             0             1
Lost to Follow-up             0             1
Did not meet entrance criteria             1             0
Arm/Group Title Celecoxib Diclofenac Total
Hide Arm/Group Description Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
18 to 44 years 2 2 4
45 to 64 years 2 2 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
4
 100.0%
3
  75.0%
7
  87.5%
Male
0
   0.0%
1
  25.0%
1
  12.5%
1.Primary Outcome
Title Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
Hide Description Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
Time Frame Baseline, Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline on VAS-pain at Day 3 and Day 14
Hide Description Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
Time Frame Baseline, Days 3, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
Hide Description 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.
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Cervical Injury
Hide Description 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).
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline on Physician’s Global Assessment of Cervical Injury
Hide Description 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).
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
Hide Description 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.
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Hide Description 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).
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
Hide Description 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).
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Participant's Responses to Neck Disability Index (NDI)
Hide Description 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.
Time Frame Baseline, Days 7, 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination.
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description:
Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Celecoxib Diclofenac
Hide Arm/Group Description Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
All-Cause Mortality
Celecoxib Diclofenac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Diclofenac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib Diclofenac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894790     History of Changes
Other Study ID Numbers: A3191352
First Submitted: March 27, 2009
First Posted: May 7, 2009
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: March 1, 2011