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

This study has been terminated.

( See termination reason in detailed description. )

Study NCT00894790 Information provided by Pfizer

First Received on March 27, 2009. Last Updated on February 25, 2011 History of Changes

Results First Received: January 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Interventions:	Drug: Celecoxib Drug: oral Diclofenac

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Celecoxib	Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac	Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care

Participant Flow: Overall Study

	Celecoxib	Diclofenac
STARTED	4	4
COMPLETED	3	2
NOT COMPLETED	1	2
Protocol Violation	0	1
Lost to Follow-up	0	1
Did not meet entrance criteria	1	0

Baseline Characteristics

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Reporting Groups

	Description
Celecoxib	Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac	Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care

Baseline Measures

	Celecoxib	Diclofenac	Total
Number of Participants [units: participants]	4	4	8
Age, Customized [units: participants]
18 to 44 years	2	2	4
45 to 64 years	2	2	4
Gender [units: participants]
Female	4	3	7
Male	0	1	1

Outcome Measures

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1. Primary:

Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain [ Time Frame: Baseline, Day 7 ]

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2. Secondary:

Change From Baseline on VAS-pain at Day 3 and Day 14 [ Time Frame: Baseline, Days 3, 14 ]

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3. Secondary:

Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates) [ Time Frame: Baseline, Days 7, 14 ]

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4. Secondary:

Change From Baseline in Patient Global Assessment of Cervical Injury [ Time Frame: Baseline, Days 7, 14 ]

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5. Secondary:

Change From Baseline on Physician’s Global Assessment of Cervical Injury [ Time Frame: Baseline, Days 7, 14 ]

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6. Secondary:

Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score [ Time Frame: Baseline, Days 7, 14 ]

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7. Secondary:

Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [ Time Frame: Baseline, Days 7, 14 ]

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8. Secondary:

Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire [ Time Frame: Baseline, Days 7, 14 ]

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9. Secondary:

Change From Baseline in Participant's Responses to Neck Disability Index (NDI) [ Time Frame: Baseline, Days 7, 14 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00894790 History of Changes
Other Study ID Numbers:	A3191352
Study First Received:	March 27, 2009
Results First Received:	January 28, 2011
Last Updated:	February 25, 2011
Health Authority:	Mexico: Ministry of Health