A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
Overview
- Phase
- Phase 4
- Intervention
- morphine sulfate and naltrexone hydrochloride (EMBEDA)
- Conditions
- Chronic Disease
- Sponsor
- Pfizer
- Enrollment
- 684
- Locations
- 159
- Primary Endpoint
- Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
Time Frame: Baseline through Week 6
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Time Frame: Baseline through Week 6
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Secondary Outcomes
- Investigator's Level of Satisfaction With the EMBEDA Conversion Guide(Week 6)
- Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)(Baseline, Visit 3 (up to Week 6))
- Number of Titration Steps to Achieve Stable Dose(Baseline through Week 6)
- Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy(Baseline through Week 6)
- Percentage of Participants With Rescue Medications Usage During Titration(Baseline through Week 6)
- Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy(Baseline through Week 6)
- Duration to Titrate Participants to Stable Dose(Baseline through Week 6)