Study of D-Methadone in Patients With Chronic Pain - Full Text View

Purpose

The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.

Condition	Intervention	Phase
Pain Bladder Cancer Breast Cancer CNS Cancer Colon Cancer Esophageal Cancer Pancreatic Cancer Prostate Cancer Uterine Cancer Head and Neck Cancer Eye Cancer Otorhinolaryngologic Neoplasms	Drug: d-Methadone Drug: D-methadone Drug: placebo	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase I/II Study of D-Methadone in Patients With Chronic Pain

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain. [ Time Frame: Once dose escalation is complete ] [ Designated as safety issue: Yes ]
Phase II: The objective of this study is to evaluate the analgesic efficacy of d-methadone in patients taking opioids for cancer related pain and in patients not taking opioids with cancer related neuropathic pain. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The scientific aim of the study is to test safety and efficacy of a possible new non-opioid analgesic. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	October 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Phase I, cohort l oral d-methadone 40 mg	Drug: d-Methadone 8 subjects to receive 40 mg d-Methadone twice a day
Experimental: Phase I, cohort 2 80 mg d-Methadone	Drug: d-Methadone 8 subjects to receive 80 mg d-Methadone twice a day
Experimental: Phase I, cohort 3 160 mg d-Methadone	Drug: d-Methadone 160 mg d-Methadone twice a day
Experimental: Phase II, Group I patients receiving around the clock opioid therapy	Drug: D-methadone After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. Drug: placebo After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
Experimental: Phase II, Group II patients not receiving around the clock opioid therapy.	Drug: D-methadone After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. Drug: placebo After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Phase I and Phase II portions of the study:

18 years of age or older
Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry.
Give informed consent to participate in this study.
Karnofsky Performance Score (KPS) >= to 80
Negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). Patients must also use a medically approved contraceptive method during the study period.

Phase I only:

Responsible companion living with patient during study.

Phase II only:

Group 1 -- Patients must be taking chronic opioid therapy (long acting morphine, long acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days. The dose of as needed short acting opioid does not need to be stable.
Group 2 -- Patients must not be receiving opioids and must have cancer related neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic neuralgia.

Exclusion Criteria:

Phase I and Phase II:

Known hypersensitivity to methadone
Patient taking methadone or with a history of methadone treatment within one month of study enrollment.
Patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment:
- Abacavir,
- Benzodiazepines,
- Carbamazepine,
- Efavirenz,
- Fluconazole,
- Fluvoxamine,
- FOS amprenavir,
- Fosphenytoin,
- Naltrexone,
- Nelfinavir,
- Nevirapine,
- Phenytoin,
- Rifampin,
- Rifapentine,
- Risperidone,
- Ritonavir,
- St. John's Wort,
- Zidovudine
Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry.
Neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection.
Women who are pregnant or nursing.
Women of childbearing potential who do not agree to use a medically recognized method of contraception during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588640

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Natalie Moryl, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588640 History of Changes
Other Study ID Numbers:	01-017
Study First Received:	December 22, 2007
Last Updated:	July 24, 2008
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Pain
HEENT cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Breast Neoplasms
Neoplasms
Colonic Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Eye Neoplasms
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Uterine Neoplasms
Central Nervous System Neoplasms
Urologic Neoplasms
Urogenital Neoplasms

Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Eye Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 17, 2012