Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
Primary Purpose
Pain
Status
Terminated
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Celecoxib
oral Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Treatment of the acute pain due to cervical, sprain, Celecoxib, NSAID, Diclofenac
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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).
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).
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.
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).
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).
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.
Full Information
NCT ID
NCT00894790
First Posted
March 27, 2009
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00894790
Brief Title
Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Treatment of the acute pain due to cervical, sprain, Celecoxib, NSAID, Diclofenac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg
Intervention Type
Drug
Intervention Name(s)
oral Diclofenac
Intervention Description
diclofenac 75 mg tablet BID (twice a day)
Primary Outcome Measure Information:
Title
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
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
Secondary Outcome Measure Information:
Title
Change From Baseline on VAS-pain at Day 3 and Day 14
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
Title
Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
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
Title
Change From Baseline in Patient Global Assessment of Cervical Injury
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
Title
Change From Baseline on Physician's Global Assessment of Cervical Injury
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
Title
Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
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
Title
Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
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
Title
Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
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
Title
Change From Baseline in Participant's Responses to Neck Disability Index (NDI)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
D.f.
ZIP/Postal Code
04500
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
D.f.
ZIP/Postal Code
11510
Country
Mexico
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191352&StudyName=Celecoxib%20Efficacy%20And%20Safety%20Versus%20%20Diclofenac%20In%20Acute%20Pain%20Due%20To%20Cervical%20Sprain%20Related%20To%20A%20Traffic%20Accident
Description
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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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