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

NCT00649610 | Completed Phase 4

• 1 other identifier: A3471012
• Study Type: interventional
• Target: 340
• Locations: 8 countries
• Sites: 27

Brief 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.

Conditions

Low Back Pain

Keywords

acute low back pain

Outcome Measures

Primary Outcomes (1)

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

  Day 3

Secondary Outcomes (7)

• Patient global evaluation

  Day 3 and Day 7

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

  Day 7

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

  Day 7

• Pain Relief

  Day 3 and Day 7

• 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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: diclofenac

Interventions

valdecoxib DRUG

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

Arm 1

diclofenac DRUG

diclofenac 75 mg twice daily (BID) for 7 days

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• History of at least 1 reported episode of acute low back pain in the last 5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Pfizer Investigational Site

Bs. As., Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1221ACI, Argentina

Location

Pfizer Investigational Site

Goiânia, Goiás, 74085-450, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80430-210, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, Brazil

Location

Pfizer Investigational Site

Petrópolis, Rio de Janeiro, 25620-040, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04029-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05001-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05403-012, Brazil

Location

Pfizer Investigational Site

Santiago, Chile

Location

Pfizer Investigational Site

Bogotá, D.C., Colombia

Location

Pfizer Investigational Site

Bogota D.C, Colombia

Location

Pfizer Investigational Site

Cali-valle, Colombia

Location

Pfizer Investigational Site

Cartago, Cartago Province, 7051, Costa Rica

Location

Pfizer Investigational Site

Hatillo Centro, Provincia de San José, 476-1002, Costa Rica

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

Toluca, EDO. de Mexico, 50080, Mexico

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45040, Mexico

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45200, Mexico

Location

Pfizer Investigational Site

Puebla City, Puebla, 72000, Mexico

Location

Pfizer Investigational Site

Puebla City, Puebla, 72070, Mexico

Location

Pfizer Investigational Site

Puebla City, Puebla, 72410, Mexico

Location

Pfizer Investigational Site

Lima, Lima Province, LIMA 11, Peru

Location

Pfizer Investigational Site

Lima, Lima Province, LIMA 27, Peru

Location

Pfizer Investigational Site

Caracas, DF, 1020, Venezuela

Location

Pfizer Investigational Site

Caracas, DF, 1051, Venezuela

Location

Pfizer Investigational Site

Caracas, DF, 1070, Venezuela

Location

Pfizer Investigational Site

Caracas, Venezuela

Location

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Interventions

valdecoxib; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: November 1, 2002
• Study Completion: May 1, 2003
• Last Updated: April 10, 2008

Record last verified: 2008-03

Locations

EC (1); CL (1); CO (3); AR (2); PE (2); BR (8); VE (4); ME (6)