Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
|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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Celecoxib Drug: oral Diclofenac||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2009|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
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)
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894790
|Pfizer Investigational Site|
|Mexico, D.f., Mexico, 04500|
|Pfizer Investigational Site|
|Mexico, D.f., Mexico, 11510|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|