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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-039-02
Enrollment
4
Registered
2002-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Valdecoxib 40 mg Type of group
Patients will be given Valdecoxib 40 mg once a day. Group name:diclofenac 75 mg Type of group
Diclofenac 75 mg twice a day.

Sponsors

PFIZER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Outcome name:Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline Measure:Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline Timepoints:day 3—

Secondary

MeasureTime frame
Outcome name:Oswestry Low Back Pain and Disability Questionnaire Measure:Subjects functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire Timepoints:day 7—

Countries

Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)