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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00630201 | Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence | PHASE3 | COMPLETED | 62 | — | — | Oct 1, 2007 | Feb 1, 2009 | Dec 31, 2018 | 15 | United States |
| NCT00447564 | Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence | PHASE3 | COMPLETED | 163 | — | — | Oct 1, 2006 | Jul 1, 2008 | Dec 31, 2018 | 18 | United States |
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
| Arm | Type | Description |
|---|---|---|
| Probuphine | EXPERIMENTAL | buprenorphine implant |
| Group A | ACTIVE_COMPARATOR | - |
| Group B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Probuphine (buprenorphine implant) | DRUG | Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration). |
| Probuphine | DRUG | 4 implants |
| placebo | DRUG | 4 implants |
Inclusion Criteria: * Voluntarily provide written informed consent prior to conduct of any study-related procedures * Completed 24 weeks of treatment in PRO-805 * Deemed appropriate for entry into this extension study by the Investigator * Females of childbearing potential and fertile males must us...