Conversion to Embeda With Rescue Trial (ConvERT)

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Chronic Disease; Pain

Treatments: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179191

B4541001

ALO-01-10-4003

Details and patient eligibility

About

The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.

Full description

The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.

Enrollment: 684 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be able to read, speak and understand English
• Have chronic moderate to severe pain for at least 3 months
• Require around the clock opioid medication for the relief of pain
• Have been taking a daily opioid for at least 30 days prior to starting the study
• Be able to be safely switched to a different pain medication
• Be practicing acceptable birth control methods for female patients of childbearing potential
• Be willing to participate in the study and able to comply with study procedures

Exclusion criteria

• Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
• Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
• Be currently taking tramadol and/or extended release morphine products
• Have respiratory depression
• Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
• Have migraines as your main source of pain
• Have any form of bowel obstruction
• Be pregnant or breast feeding
• Have had 2 or more surgeries for low back pain
• Be planning a major surgery during the study
• Be staying in a hospital or nursing home
• Be planning to have steroid injections for your chronic pain during the study
• Have a life expectancy of less than 2 months

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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684 participants in 1 patient group

morphine sulfate and naltrexone hydrochloride (EMBEDA)

Experimental group

Treatment:

Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)