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

Condition(s) targeted: Low Back Pain

Intervention: valdecoxib (Drug); diclofenac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Patient global evaluation

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

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

Pain Relief

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

VAS Pain Intensity (0-100 mm)

Categorical Pain Intensity

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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:

- 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

Pfizer Investigational Site, Bs. As., Argentina

Pfizer Investigational Site, BUENOS AIRES C1221ACI, Argentina

Pfizer Investigational Site, SAO PAULO 05001-000, Brazil

Pfizer Investigational Site, SANTIAGO, Chile

Pfizer Investigational Site, CALI-VALLE, Colombia

Pfizer Investigational Site, BOGOTA D.C, Colombia

Pfizer Investigational Site, PUEBLA 72410, Mexico

Pfizer Investigational Site, PUEBLA 72000, Mexico

Pfizer Investigational Site, PUEBLA 72070, Mexico

Pfizer Investigational Site, LIMA LIMA 27, Peru

Pfizer Investigational Site, LIMA LIMA 11, Peru

Pfizer Investigational Site, CARACAS, Venezuela

Pfizer Investigational Site, CARTAGO CITY, CARTAGO 7051, Costa Rica

Pfizer Investigational Site, BOGOTA, D.C., Colombia

Pfizer Investigational Site, CARACAS, DF 1020, Venezuela

Pfizer Investigational Site, CARACAS, DF 1070, Venezuela

Pfizer Investigational Site, CARACAS, DF 1051, Venezuela

Pfizer Investigational Site, TOLUCA, Edo. De Mexico 50080, Mexico

Pfizer Investigational Site, GOIANIA, GOIAS 74085-450, Brazil

Pfizer Investigational Site, ZAPOPAN, JALISCO 45040, Mexico

Pfizer Investigational Site, ZAPOPAN, JALISCO 45200, Mexico

Pfizer Investigational Site, CURITIBA, PARANA 80430-210, Brazil

Pfizer Investigational Site, QUITO, PICHINCHA, Ecuador

Pfizer Investigational Site, CURITIBA, PR, Brazil

Pfizer Investigational Site, PETROPOLIS, Rio De Janeiro 25620-040, Brazil

Pfizer Investigational Site, HATILLO, SAN JOSE 476-1002, Costa Rica

Pfizer Investigational Site, SAO PAULO, SP 04023-900, Brazil

Pfizer Investigational Site, SAO PAULO, SP 05403-012, Brazil

Pfizer Investigational Site, SAO PAULO, SP 04029-000, Brazil

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: November 2002
Ending date: May 2003
Last updated: April 7, 2008