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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00558870 |
Primary Objective:
To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days)
Secondary Objectives:
To determine whether individuals on the methadone arm have lower pain intensity than the morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in their ESAS score at Day 15 (+/- 3 days).
To determine whether the methadone group of experiences fewer opioid induced neurotoxic side effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as compared to the morphine alone group at Day 15 (+/- 3 days).
Condition | Intervention | Phase |
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Pain |
Drug: Morphine Drug: Methadone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Role of Methadone As Co-Opioid Analgesic in Cancer Patients |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Morphine Only
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Drug: Morphine
Arm 1: 2 Doses of "Slow-Release" Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)."Immediate-release" morphine may be used, if needed, for pain.
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2: Active Comparator
Morphine + Methadone
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Drug: Methadone
1 Dose of Methadone PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days) Arm 2: 1 Dose of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).)."Immediate-release" morphine may be used, if needed, for pain. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sriram Yennurajalingam, MD | 713-792-6085 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Sriram Yennurajalingam, MD |
Principal Investigator: | Sriram Yennurajalingam, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sriram Yennurajalingam, MD/Assistant Professor ) |
Study ID Numbers: | 2006-0641 |
Study First Received: | November 14, 2007 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00558870 |
Health Authority: | United States: Institutional Review Board |
Solid Tumors Morphine Methadone Co-Opioid Analgesic Pain |
Naphazoline Oxymetazoline Morphine Methadone |
Guaifenesin Phenylephrine Pain Phenylpropanolamine |
Respiratory System Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |