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OpenTrials
Completed

NCT Number: NCT00640432

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

To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Completed

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Salvador, Estado de Bahia, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

75 mg oral capsule twice daily for 7 days

Celecoxib

Drug

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

Primary outcomes

  1. Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment

    Time frame: Day 3

Secondary outcomes

  1. Subject's quality of life, as measured by the SF-36 Health Survey

    Time frame: Day 7

  2. Physical examination

    Time frame: Days 3 and 7

  3. Pain relief score

    Time frame: Days 3 and 7

  4. Vital signs

    Time frame: Days 3 and 7

  5. Adverse events

    Time frame: Days 3 and 7

  6. Change from baseline in VAS pain intensity assessment

    Time frame: Day 7

  7. Categorical pain intensity score

    Time frame: Days 3 and 7

  8. Subject's global assessment score

    Time frame: Days 3 and 7

  9. Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 21, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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