Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

NCT00640432

Last updated date
Study Location
Pfizer Investigational Site
Salvador, BA, 40420-000, Brazil
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
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
  • Drug: Diclofenac
    75 mg oral capsule twice daily for 7 days
  • Drug: Celecoxib
    400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Diclofenac
  • Experimental: B
    Intervention: Drug: Celecoxib
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
 (submitted: March 20, 2008)
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:

  • 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

Exclusion criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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