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A Phase I/II Study of D-Methadone in Patients With Chronic Pain


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

A Phase I/II Study of D-Methadone in Patients With Chronic Pain


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase I: The objective of this study is to determine a safe and well tolerated dose of d-methadone in patients with chronic pain.

Outcome Time Frame:

Once dose escalation is complete

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

01-017

NCT ID:

NCT00588640

Start Date:

October 2004

Completion Date:

July 2008

Related Keywords:

  • 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
  • Pain
  • HEENT cancer
  • 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

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021