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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: Celecoxib
* Drug: oral Diclofenac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Celecoxib<br>* celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg<br>|
| Active Comparator: 2<br> | Drug: oral Diclofenac<br>* diclofenac 75 mg tablet BID (twice a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on VAS-pain at Day 3 and Day 14 | Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain). | Baseline, Days 3, 14 | 
| Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates) | 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. | Baseline, Days 7, 14 | 
| Change From Baseline in Patient Global Assessment of Cervical Injury | 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). | Baseline, Days 7, 14 | 
| Change From Baseline on Physician's Global Assessment of Cervical Injury | 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). | Baseline, Days 7, 14 | 
| Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score | 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. | Baseline, Days 7, 14 | 
| Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | 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). | Baseline, Days 7, 14 | 
| Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire | 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). | Baseline, Days 7, 14 | 
| Change From Baseline in Participant's Responses to Neck Disability Index (NDI) | 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. | Baseline, Days 7, 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of the acute pain due to cervical, sprain, Celecoxib, NSAID, Diclofenac