General Information
Purdue Pharma CLBP ONU3701
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial with an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-Release Tablets (OXN) Compared to Placebo in Opioid-Experienced Subjects with Moderate to Severe Pain Due to Chronic Low Back Pain who Require Around-the-clock Opioid Therapy.
| Protocol | |
|---|---|
| Identifier | ONU3701 |
| UID | 185423f5-e912-43cb-91ff-62439f444a61 |
| Status | Done - Archived |
| Phase | 3 |
| Category | Low Back Pain |
| Launch Year | 2011 |
| NCT Number | - |
| Created | 2011-04-06 16:52 |
| Last Updated | 2011-04-06 16:52 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2012-05-25 | No |
| Enrollment Open | No | |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2011-09-01 | No |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2012-12-21 | 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 | Mohaupt, Stephen | SMohaupt | 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 | 26036/14 |
|---|---|
| CRO | PPD Investigator Services, LLC |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
