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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649610
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 22, 2013