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Clinical Trial Name - Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
| Original Study ID : A3191064 |
| NCT ID : NCT00640432 |
| Brief Title : Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain |
| Official Title : A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain |
| Brief Summary : To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : October 2003 |
| End Date : October 2004 |
| Completion Date : October 2004 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 244 |
| Verification Date : March 2008 |
| First Received Date : March 17, 2008 |
| Trial Eligibility |
| Criteria : Inclusion criteria: - Aged between 18 and 65 years - Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS) - Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode Exclusion criteria: - Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain - Low back pain from major trauma or visceral disorder - Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 65 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Salvador |
| State : BA |
| Zip Code : 40420-000 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Goiânia |
| State : GO |
| Zip Code : 74605-050 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Goiânia |
| State : GO |
| Zip Code : 74075-020 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Goiânia |
| State : GO |
| Zip Code : 74043-110 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Londrina |
| State : PR |
| Zip Code : 86010-010 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Rio de Janeiro |
| State : RJ |
| Zip Code : 21215-020 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : Rio de Janeiro |
| State : RJ |
| Zip Code : 21941-590 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : São Paulo |
| State : SP |
| Zip Code : 04039-004 |
| Country : Brazil |
| Facility Name : Pfizer Investigational Site |
| City : São Paulo |
| State : SP |
| Zip Code : 08270-070 |
| Country : Brazil |
| OutComes |
| Primary OutComes |
| Measure : Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment |
| Time Frame : Day 3 |
| Safety issue : No |
| Secondary OutComes |
| Measure : Subject's quality of life, as measured by the SF-36 Health Survey |
| Time Frame : Day 7 |
| Safety issue : No |
| Measure : Physical examination |
| Time Frame : Days 3 and 7 |
| Safety issue : Yes |
| Measure : Pain relief score |
| Time Frame : Days 3 and 7 |
| Safety issue : No |
| Measure : Vital signs |
| Time Frame : Days 3 and 7 |
| Safety issue : Yes |
| Measure : Adverse events |
| Time Frame : Days 3 and 7 |
| Safety issue : Yes |
| Measure : Change from baseline in VAS pain intensity assessment |
| Time Frame : Day 7 |
| Safety issue : No |
| Measure : Categorical pain intensity score |
| Time Frame : Days 3 and 7 |
| Safety issue : No |
| Measure : Subject's global assessment score |
| Time Frame : Days 3 and 7 |
| Safety issue : No |
| Measure : Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability |
| Time Frame : Day 7 |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : Diclofenac |
| Description : 75 mg oral capsule twice daily for 7 days |
| Type : Drug |
| Name : Celecoxib |
| Description : 400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days |
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