Overview

Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

Status:
Terminated

Trial end date:
2005-07-01

Target enrollment:
0

Participant gender:
All

Summary

The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Purdue Pharma LP

Treatments:

Hydromorphone

Criteria

Inclusion Criteria:

- persistent, moderate-to-severe noncancer related pain requiring continuous analgesia
for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or
opioid equivalents per day for control of their persistent pain and who are willing to
accept the possibility of receiving placebo during the Double-Blind Phase

Exclusion Criteria:

- Patients already receiving opioid medication at an average total daily dose greater
than 40 mg of oxycodone or opioid equivalents during the last week prior to study
entry.

Other protocol-specific exclusion/inclusion criteria may apply.