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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649610
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: valdecoxib
Drug: diclofenac
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient global evaluation [ Time Frame: Day 3 and Day 7 ] [ Designated as safety issue: No ]
  • Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Pain Relief [ Time Frame: Day 3 and Day 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • VAS Pain Intensity (0-100 mm) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Categorical Pain Intensity [ Time Frame: Day 3 and Day 7 ] [ Designated as safety issue: No ]

Enrollment: 340
Study Start Date: November 2002
Study Completion Date: May 2003
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
Active Comparator: Arm 2 Drug: diclofenac
diclofenac 75 mg twice daily (BID) for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649610

Locations
Argentina
Pfizer Investigational Site
Bs. As., Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1221ACI
Brazil
Pfizer Investigational Site
Goiania, Goias, Brazil, 74085-450
Pfizer Investigational Site
Curitiba, Parana, Brazil, 80430-210
Pfizer Investigational Site
Curitiba, PR, Brazil
Pfizer Investigational Site
Petropolis, Rio de Janeiro, Brazil, 25620-040
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04023-900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 05403-012
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04029-000
Pfizer Investigational Site
Sao Paulo, Brazil, 05001-000
Chile
Pfizer Investigational Site
Santiago, Chile
Colombia
Pfizer Investigational Site
Bogota, D.c., Colombia
Pfizer Investigational Site
Bogota D.c, Colombia
Pfizer Investigational Site
Cali-valle, Colombia
Costa Rica
Pfizer Investigational Site
Cartago City, Cartago, Costa Rica, 7051
Pfizer Investigational Site
Hatillo, San Jose, Costa Rica, 476-1002
Ecuador
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Mexico
Pfizer Investigational Site
Toluca, Edo. de Mexico, Mexico, 50080
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45040
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45200
Pfizer Investigational Site
Puebla, Mexico, 72410
Pfizer Investigational Site
Puebla, Mexico, 72000
Pfizer Investigational Site
Puebla, Mexico, 72070
Peru
Pfizer Investigational Site
Lima, Peru, LIMA 27
Pfizer Investigational Site
Lima, Peru, LIMA 11
Venezuela
Pfizer Investigational Site
Caracas, DF, Venezuela, 1020
Pfizer Investigational Site
Caracas, DF, Venezuela, 1051
Pfizer Investigational Site
Caracas, DF, Venezuela, 1070
Pfizer Investigational Site
Caracas, Venezuela
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649610     History of Changes
Other Study ID Numbers: A3471012
Study First Received: March 28, 2008
Last Updated: April 7, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Pfizer:
acute low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014