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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00649610

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 IV

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:

MedlinePlus related topics: Back Pain

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Valdecoxib

U.S. FDA Resources

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
Arm 1: Active Comparator	Drug: valdecoxib valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
Arm 2: Active Comparator	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

Show 29 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
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

ClinicalTrials.gov processed this record on September 02, 2010