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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00857623 | Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy | PHASE2 | COMPLETED | 127 | — | — | Feb 1, 2009 | Aug 1, 2009 | Nov 12, 2012 | 19 | United States |
| NCT00829088 | Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066 | PHASE1 | COMPLETED | 6 | — | — | Jan 1, 2009 | Feb 1, 2009 | Feb 25, 2009 | 1 | United Kingdom |
| NCT00684502 | Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects | PHASE1 | COMPLETED | 110 | — | — | Jan 1, 2008 | Nov 1, 2008 | Dec 10, 2010 | 1 | Sweden |
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD2066 | DRUG | Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. |
| Placebo | DRUG | Capsule, once daily |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Clinical diagnosis of painful diabetic neuropathy. * non-fertile females Exclusion Criteria: * Other pain that may confound assessment of neuropathic pain. * Ongoing significant peripheral arterial disea...