General Information
Purdue CLBP - Controlled 3705
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects with Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid
| Protocol | ONU3705 |
|---|---|
| Identifier | ONU3705 Site Number 1368A |
| UID | f12cea21-edb1-4328-ae75-10192d658c7c |
| Status | Done - Archived |
| Phase | 3 |
| Category | Low Back Pain / Adult |
| Launch Year | 2011 |
| NCT Number | - |
| Created | 2011-10-10 13:27 |
| Last Updated | 2011-10-10 13:27 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2014-05-09 | No |
| Enrollment Open | No | |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2011-12-27 | No |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2014-12-11 | 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 | Soler, Daniel | DSoler | No |
| Regulatory | Aguirre, Sandra | SAguirre | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Purdue Pharma LP |
|---|---|
| Division | Purdue Pharma LP |
| Team | Purdue Pharma LP |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | QUI1-11-243 |
|---|---|
| CRO | IQVIA RDS Inc. |
| CRO Ref | IntraLinks - workspace |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
