- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00894790
Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
D.f.
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Mexico, D.f., Mexico, 04500
- Pfizer Investigational Site
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Mexico, D.f., Mexico, 11510
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
|
diclofenac 75 mg tablet BID (twice a day)
|
EXPERIMENTAL: 1
|
celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
|
What is the study measuring?
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
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).
|
Baseline, Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, Days 3, 14
|
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.
|
Baseline, Days 7, 14
|
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).
|
Baseline, Days 7, 14
|
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).
|
Baseline, Days 7, 14
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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.
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Baseline, Days 7, 14
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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).
|
Baseline, Days 7, 14
|
Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
Time Frame: Baseline, Days 7, 14
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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).
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Baseline, Days 7, 14
|
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.
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Baseline, Days 7, 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
March 27, 2009
First Submitted That Met QC Criteria
May 6, 2009
First Posted (ESTIMATE)
May 7, 2009
Study Record Updates
Last Update Posted (ACTUAL)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 29, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Acute Pain
- Sprains and Strains
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
- Diclofenac
Other Study ID Numbers
- A3191352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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