drugset / Trial / NCT00679146

Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain

NCT00679146

Phase 3 Completed 334 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective : To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset Secondary Objective : To compare the safety of the oral combination to that of oral TCC alone

Timeline

Start
2008-04
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketoprofen Small molecule 100 mg Oral
Comparator Thiocolchicoside Small molecule 4 mg Oral
Comparator Thiocolchicoside Small molecule 8 mg Oral

Indications

No indication recorded.