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Completed

NCT Number: NCT00649610

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.

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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, Bs. As., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
  • Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
  • History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion criteria

  • History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
  • Moderate to severe scoliosis
  • Back pain due to major trauma or visceral disorder
  • Unwilling to refrain from commencing concomitant physiotherapy
  • Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
  • Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
  • Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception

Treatment and study plan

valdecoxib

Drug

valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

Diclofenac

Drug

diclofenac 75 mg twice daily (BID) for 7 days

Primary outcomes

  1. Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline

    Time frame: Day 3

Secondary outcomes

  1. Patient global evaluation

    Time frame: Day 3 and Day 7

  2. Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire

    Time frame: Day 7

  3. Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)

    Time frame: Day 7

  4. Pain Relief

    Time frame: Day 3 and Day 7

  5. Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia

    Time frame: Day 7

  6. VAS Pain Intensity (0-100 mm)

    Time frame: Day 7

  7. Categorical Pain Intensity

    Time frame: Day 3 and Day 7

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain

Important dates

Study start
2002
Study completion
2003
First posted
Apr 1, 2008
Registry last updated
Apr 10, 2008

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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