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

Low Back Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649610
• Other study ID #: A3471012
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: April 7, 2008
• Start date: November 2002
• Est. completion date: May 2003

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• valdecoxib
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
• diclofenac
diclofenac 75 mg twice daily (BID) for 7 days

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Bs. As.
Argentina	Pfizer Investigational Site	Buenos Aires
Brazil	Pfizer Investigational Site	Curitiba	Parana
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Goiania	Goias
Brazil	Pfizer Investigational Site	Petropolis	Rio de Janeiro
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Bogota	D.c.
Colombia	Pfizer Investigational Site	Bogota D.c
Colombia	Pfizer Investigational Site	Cali-valle
Costa Rica	Pfizer Investigational Site	Cartago City	Cartago
Costa Rica	Pfizer Investigational Site	Hatillo	San Jose
Ecuador	Pfizer Investigational Site	Quito	Pichincha
Mexico	Pfizer Investigational Site	Puebla
Mexico	Pfizer Investigational Site	Puebla
Mexico	Pfizer Investigational Site	Puebla
Mexico	Pfizer Investigational Site	Toluca	Edo. de Mexico
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Venezuela	Pfizer Investigational Site	Caracas	DF
Venezuela	Pfizer Investigational Site	Caracas	DF
Venezuela	Pfizer Investigational Site	Caracas	DF
Venezuela	Pfizer Investigational Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline		Day 3	No
Secondary	Patient global evaluation		Day 3 and Day 7	No
Secondary	Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire		Day 7	No
Secondary	Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)		Day 7	No
Secondary	Pain Relief		Day 3 and Day 7	No
Secondary	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		Day 7	Yes
Secondary	VAS Pain Intensity (0-100 mm)		Day 7	No
Secondary	Categorical Pain Intensity		Day 3 and Day 7	No

External Links

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