Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 334 | — | — | Apr 1, 2008 | Jun 1, 2009 | Jun 11, 2010 | 6 | Brazil, Colombia +4 |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d |
| 2 | ACTIVE_COMPARATOR | 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d |
| Name | Type | Description |
|---|---|---|
| Thiocolchicoside+Ketoprofen | DRUG | 1 tablet TCC 8 mg + ketoprofen 100 mg b.i.d + 2 tablets TCC placebo b.i.d |
| Thiocolchicoside | DRUG | 2 tablets TCC 4 mg b.i.d. + 1 tablet of FDC placebo b.i.d |
List of Inclusion and Exclusion criteria : Inclusion Criteria: * Non specific low back pain with an acute episode of recent onset (\<48 hours) defined by average pain within the last 24 hours equal or more than 50 mm on the Visual Analogue Scale (VAS) * Low back pain of diagnosis category 1 (low b...