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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00894790
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 4
• Patients Per Site Per Month: 2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Celecoxib; Drug: oral Diclofenac	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Nov 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Celecoxib; 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)

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain [Baseline, Day 7]

   Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

Secondary Outcome Measures

1. Change From Baseline on VAS-pain at Day 3 and Day 14 [Baseline, Days 3, 14]

   Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).

2. Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates) [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.

3. Change From Baseline in Patient Global Assessment of Cervical Injury [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).

4. Change From Baseline on Physician's Global Assessment of Cervical Injury [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).

5. Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score [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.

6. Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [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).

7. Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire [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).

8. Change From Baseline in Participant's Responses to Neck Disability Index (NDI) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mexico	D.f.	Mexico	04500
2	Pfizer Investigational Site	Mexico	D.f.	Mexico	11510

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00894790
• Other Study ID Numbers: A3191352
• First Posted: May 7, 2009
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Treatment of the acute pain due to cervical; sprain; Celecoxib; NSAID; Diclofenac
• Additional relevant MeSH terms: Acute Pain; Sprains and Strains; Celecoxib; Diclofenac

Study Results

Participant Flow

Arm/Group Title	Celecoxib	Diclofenac
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

Baseline Characteristics

Arm/Group Title	Celecoxib	Diclofenac	Total
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 Participants	4	4	8
Age, Customized (participants) [Number]
18 to 44 years	2 50%	2 50%	4 50%
45 to 64 years	2 50%	2 50%	4 50%
Sex: Female, Male (Count of Participants)
Female	4 100%	3 75%	7 87.5%
Male	0 0%	1 25%	1 12.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination.

Arm/Group Title	Celecoxib	Diclofenac
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
Measure Participants	0	0

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Celecoxib		Diclofenac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Celecoxib		Diclofenac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.