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Clinical Trial Name - Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Da
| Original Study ID : A3471012 |
| NCT ID : NCT00649610 |
| Brief Title : 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 |
| 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 |
| 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. |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : November 2002 |
| End Date : May 2003 |
| Completion Date : May 2003 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 340 |
| Verification Date : March 2008 |
| First Received Date : March 28, 2008 |
| Trial Eligibility |
| 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 65 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Bs. As. |
| Country : Argentina |
| Facility Name : Pfizer Investigational Site |
| City : BUENOS AIRES |
| Zip Code : C1221ACI |
| Country : Argentina |
| Facility Name : Pfizer Investigational Site |
| City : SAO PAULO |
| Zip Code : 05001-000 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : GOIANIA |
| State : GOIAS |
| Zip Code : 74085-450 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : CURITIBA |
| State : PARANA |
| Zip Code : 80430-210 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : CURITIBA |
| State : PR |
| Zip Code : 80430-210 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : PETROPOLIS |
| State : Rio De Janeiro |
| Zip Code : 25620-040 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : SAO PAULO |
| State : SP |
| Zip Code : 04023-900 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : SAO PAULO |
| State : SP |
| Zip Code : 05403-012 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : SAO PAULO |
| State : SP |
| Zip Code : 04029-000 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : SANTIAGO |
| State : SP |
| Zip Code : 04029-000 |
| Country : Chile |
| Facility Name : Pfizer Investigational Site |
| City : CALI-VALLE |
| State : SP |
| Zip Code : 04029-000 |
| Country : Colombia |
| Facility Name : Pfizer Investigational Site |
| City : BOGOTA D.C |
| State : SP |
| Zip Code : 04029-000 |
| Country : Colombia |
| Facility Name : Pfizer Investigational Site |
| City : BOGOTA |
| State : D.C. |
| Zip Code : 04029-000 |
| Country : Colombia |
| Facility Name : Pfizer Investigational Site |
| City : CARTAGO CITY |
| State : CARTAGO |
| Zip Code : 7051 |
| Country : Costa Rica |
| Facility Name : Pfizer Investigational Site |
| City : HATILLO |
| State : SAN JOSE |
| Zip Code : 476-1002 |
| Country : Costa Rica |
| Facility Name : Pfizer Investigational Site |
| City : QUITO |
| State : PICHINCHA |
| Zip Code : 476-1002 |
| Country : Ecuador |
| Facility Name : Pfizer Investigational Site |
| City : PUEBLA |
| State : PICHINCHA |
| Zip Code : 72410 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : PUEBLA |
| State : PICHINCHA |
| Zip Code : 72000 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : PUEBLA |
| State : PICHINCHA |
| Zip Code : 72070 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : TOLUCA |
| State : Edo. De Mexico |
| Zip Code : 50080 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : ZAPOPAN |
| State : JALISCO |
| Zip Code : 45040 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : ZAPOPAN |
| State : JALISCO |
| Zip Code : 45200 |
| Country : Mexico |
| Facility Name : Pfizer Investigational Site |
| City : LIMA |
| State : JALISCO |
| Zip Code : LIMA 27 |
| Country : Peru |
| Facility Name : Pfizer Investigational Site |
| City : LIMA |
| State : JALISCO |
| Zip Code : LIMA 11 |
| Country : Peru |
| Facility Name : Pfizer Investigational Site |
| City : CARACAS |
| State : JALISCO |
| Zip Code : LIMA 11 |
| Country : Venezuela |
| Facility Name : Pfizer Investigational Site |
| City : CARACAS |
| State : DF |
| Zip Code : 1020 |
| Country : Venezuela |
| Facility Name : Pfizer Investigational Site |
| City : CARACAS |
| State : DF |
| Zip Code : 1070 |
| Country : Venezuela |
| Facility Name : Pfizer Investigational Site |
| City : CARACAS |
| State : DF |
| Zip Code : 1051 |
| Country : Venezuela |
| OutComes |
| Primary OutComes |
| Measure : Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline |
| Time Frame : Day 3 |
| Safety issue : No |
| Secondary OutComes |
| Measure : Patient global evaluation |
| Time Frame : Day 3 and Day 7 |
| Safety issue : No |
| Measure : Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire |
| Time Frame : Day 7 |
| Safety issue : No |
| Measure : Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains) |
| Time Frame : Day 7 |
| Safety issue : No |
| Measure : Pain Relief |
| Time Frame : Day 3 and Day 7 |
| Safety issue : No |
| Measure : 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 dyspepsi |
| Time Frame : Day 7 |
| Safety issue : Yes |
| Measure : VAS Pain Intensity (0-100 mm) |
| Time Frame : Day 7 |
| Safety issue : No |
| Measure : Categorical Pain Intensity |
| Time Frame : Day 3 and Day 7 |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : valdecoxib |
| Description : valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day |
| Type : Drug |
| Name : diclofenac |
| Description : diclofenac 75 mg twice daily (BID) for 7 days |
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