General Information
Endo Low Back Pain 307
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter, Randomized Withdrawal Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Bema® Buprenorphine in Opioid Experienced Subjects with Moderate to Severe Chronic Low Back Pain Requiring Around-The-Clock Opioid Analgesia for an Extended Period of Time.
| Protocol | EN3409-307 |
|---|---|
| Identifier | EN3409-307 Site Number 1034 |
| UID | 145af7fd-e6d7-4a16-adc4-5fea933fe734 |
| Status | Done - Archived |
| Phase | 3 |
| Category | Low Back Pain / Adult |
| Launch Year | 2012 |
| NCT Number | - |
| Created | 2012-09-10 13:46 |
| Last Updated | 2012-09-10 13:46 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2013-08-02 | No |
| Enrollment Open | 2012-10-02 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | No | |
| PI Meeting Start | 2012-09-29 | No |
| PI Meeting End | 2012-09-30 | No |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2014-07-18 | No |
| Final PatientVisit | No | |
| PreStudy Selection Visit | No | |
| Target Date 12 | No | |
| Target Date 13 | No | |
| Target Date 14 | No |
Leadership
| Role | Staff | Login | Required |
|---|---|---|---|
| Principal | Martinez, Gilbert | GJMartinez | No |
| Recruiter | - | No | |
| Coordinator | Melendez, Jose | JMelendez | No |
| Regulatory | Aguirre, Sandra | SAguirre | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Endo Pharmaceuticals, Inc |
|---|---|
| Division | Endo Pharmaceuticals, Inc |
| Team | Endo Pharmaceuticals, Inc |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | IRB ID No. 201207543 |
|---|---|
| CRO | PRA (NC) |
| CRO Ref | SIV waived as site attended IM 09/29-30/2012 |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
