General Information
Purdue CLBP - Uncontrolled 3704
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 Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioi
| Protocol | ONU3704 |
|---|---|
| Identifier | ONU3704 Site Number 1368A |
| UID | 0204e284-e124-4de0-8baf-f395f366f415 |
| Status | Done - Archived |
| Phase | 3 |
| Category | Low Back Pain |
| Launch Year | 2011 |
| NCT Number | - |
| Created | 2011-10-10 13:57 |
| Last Updated | 2011-10-10 13:57 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 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 | 2014-01-30 | 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 | Mata, Nelly | NMata | No |
| Regulatory | - | 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 | IRB ID NO. QUI1-11-242 |
|---|---|
| CRO | IQVIA RDS Inc. |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
