Conversion to Embeda With Rescue Trial

Phase 4

Terminated

• Conditions: Chronic Disease; Pain
• Interventions: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)

• Registration Number: NCT01179191
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-07-30
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2012-04-05
• Disposition First Submitted QC: 2012-04-05
• Disposition First Posted: 2012-04-09
• Results First Submitted: 2012-07-30
• Results First Submitted QC: 2012-07-30
• Results First Posted: 2012-09-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 684

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
morphine sulfate and naltrexone hydrochloride (EMBEDA)	morphine sulfate and naltrexone hydrochloride (EMBEDA)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)	Baseline, Visit 3 (up to Week 6)	BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Number of Titration Steps to Achieve Stable Dose	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.
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy	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 With Rescue Medications Usage During Titration	Baseline through Week 6	Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy	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.
Duration to Titrate Participants to Stable Dose	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.
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide	Week 6	The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.

Trial Locations

Locations (159)

Adamsville Family Medicine; 🇺🇸 Adamsville, Alabama, United States

Office of David McLain; 🇺🇸 Birmingham, Alabama, United States

Monte Sano Clinical Research, LLC; 🇺🇸 Huntsville, Alabama, United States

Tennessee Valley Pain Consultants Properties, LLC; 🇺🇸 Huntsville, Alabama, United States

Sunbelt Research Group, LLC; 🇺🇸 Mobile, Alabama, United States

Office of Vaughn H. Mancha, Jr., PC; 🇺🇸 Montgomery, Alabama, United States

Dedicated Clinical Research; 🇺🇸 Goodyear, Arizona, United States

Dedicated Clinical Research, Inc; 🇺🇸 Phoenix, Arizona, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

Anasazi Internal Medicine, PC; 🇺🇸 Phoenix, Arizona, United States

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