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

Phase 3TerminatedNCT00365898

Purdue Pharma LP380 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Chronic Non-Malignant Pain

Interventions

Hydromorphone Hydrochloride Extended-ReleaseDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Arizona Research Center 2525 W. Greenway Rd. Suite 114

Phoenix, Arizona, United States

Clinical Research of West Florida, Inc. 2147 NE Coachman Road

Clearwater, Florida, United States

Outcomes

Primary Outcomes

Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio

Secondary Outcomes

Patient Global Assessment of Pain Medication

Pain Control Questionnaire

Data from ClinicalTrials.gov

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