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

Purdue Pharma

Status and phase

Terminated

Phase 3

Conditions

Chronic Non-Malignant Pain

Treatments

Drug: Hydromorphone Hydrochloride Extended-Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00365898

HMP3011

Details and patient eligibility

About

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

Full description

The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.