Trial intelligence / Profile preview

ConvERT: EMBEDA Conversion in Chronic Pain

NCT01179191Phase 4

Key facts

Status: Terminated
Start: Aug 2010
Primary completion: Apr 2011
Countries: 1
Sponsor: Pfizer
Modality: Small Molecules

Drugs: Embeda
Conditions: chronic pain

Overview

Phase 4, open-label, single-arm trial of Embeda in chronic pain, sponsored by Pfizer. Primary endpoint: Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase. Started Aug 2010; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

EMBEDA
Morphine sulfate and naltrexone hydrochloride capsules

Who it enrols

Opioid-experienced patients with chronic moderate to severe pain requiring around-the-clock opioid medication.

Endpoints

Primary

Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase6 weeks

Secondary

Duration to Titrate Participants to Stable Dose6 weeks
Number of Titration Steps to Achieve Stable Dose6 weeks
Percentage of Participants With Rescue Medications Usage During Titration6 weeks
Change From Baseline in Brief Pain Inventory (BPI)6 weeks
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide6 weeks

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