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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01463397 | Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain | PHASE2 | COMPLETED | 191 | — | — | Mar 1, 2012 | May 1, 2013 | Feb 26, 2016 | 61 | United States, Czechia +5 |
The average daily pain intensity is the mean of the last consecutive 7 days.
| Arm | Type | Description |
|---|---|---|
| SAR292833 dose level 1 | EXPERIMENTAL | Dose level 1 twice daily immediately after breakfast/dinner |
| SAR292833 dose level 2 | EXPERIMENTAL | Dose level 2 twice daily immediately after breakfast/dinner |
| Placebo | PLACEBO_COMPARATOR | Placebo (for SAR292833) twice daily immediately after breakfast/dinner |
| Name | Type | Description |
|---|---|---|
| SAR292833 | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| placebo | DRUG | Pharmaceutical form:capsule Route of administration: oral |
Inclusion criteria: -The study will include adult patients of either gender, 18 - 85 of age, who have signed the informed consent form, and presenting with chronic peripheral neuropathic pain associated with: diabetic polyneuropathy, post-herpetic neuralgia. * The neuropathic pain must have a dist...