Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
NCT00640432
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Aged between 18 and 65 years
- Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
- Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode
- Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis,
Paget's disease, or any other disease that cause pain
- Low back pain from major trauma or visceral disorder
- Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to
being administered study drug
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Descriptive Information | ||||
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Brief Title ICMJE | Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain | |||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain | |||
Brief Summary | To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Low Back Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 244 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00640432 | |||
Other Study ID Numbers ICMJE | A3191064 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |