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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01928381 | Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability | PHASE2 | COMPLETED | 150 | — | — | Nov 1, 2013 | May 1, 2015 | Oct 3, 2016 | 9 | United States |
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
| Arm | Type | Description |
|---|---|---|
| placebo capsules | PLACEBO_COMPARATOR | Capsules to match pregabalin and AZD5213 |
| AZD5213 + pregabalin | EXPERIMENTAL | AZD5213 in combination with pregabalin |
| pregabalin | ACTIVE_COMPARATOR | pregabalin capsules |
| Name | Type | Description |
|---|---|---|
| AZD5213 + pregabalin | DRUG | Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules) |
| Placebo | DRUG | Double blind placebo capsules to match AZD5213 and pregabalin |
| pregabalin capsules | DRUG | Double blind pregabalin capsules to match AZD5213 and placebo |
Inclusion Criteria: 1\. Male or female, age 18 to 75 years, inclusive, at Screen. 2. Subjects must provide informed consent in accordance with local regulations before the conduct of any study-related procedures. The informed consent should reflect the protocol stipulations concerning the use of co...