Methadone Versus Morphine for Cancer-Related Pain
The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Methadone Versus Morphine for Moderate to Severe Cancer-Related Pain: A Double-Blind Randomized Parallel Group Study|
- The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
Active Comparator: Morphine
Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
Treatment of cancer pain is based on the World Health Organization (WHO) step ladder approach to the use of analgesic drugs. Medication potency increases at each step of the WHO ladder, from nonopioid (step 1; e.g., aspirin and nonsteroidal anti-inflammatory drugs) through weak opioids (step 2; e.g. codeine) plus a nonopioid to strong opioids (step 3; e.g., morphine) plus a nonopioid analgesic. Morphine is considered the gold standard for the treatment of moderate to severe pain, but this is based on level C criteria. Research has discovered that methadone is a potent opioid that operates at several levels which are important for pain control. The primary aim is to compare morphine versus methadone as a first-line analgesic in patients with moderate to severe cancer pain. Patients will be randomized to receive either oral slow-release morphine (15 mg) every 8 hours and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain or oral methadone 2.5 mg every 8 hours and methadone 2.5 mg every 4 hours as needed for breakthrough pain. Our hypothesis is that methadone will provide equivalent pain control efficacy after 4 weeks of therapy. We postulate that methadone will be as preferable as morphine as an analgesic. We will compare the two drugs via adverse effects and compare stability of analgesia via comparison of the number of breakthrough pain episodes. The study will attempt to establish equivalency of methadone as a first-line analgesic for moderate to severe cancer pain.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573937
|United States, Arizona|
|Mayo Clinic Arizona|
|Scottsdale, Arizona, United States, 85259|
|Principal Investigator:||Eric E. Prommer, M.D.||Mayo Clinic|