RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine. PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

Condition	Treatment or Intervention	Phase
constipation, impaction, and bowel obstruction unspecified adult solid tumor, protocol specific	Drug: naloxone	Phase III

Further Study Details: 

OBJECTIVES: I. Assess the long-term safety and efficacy of oral naloxone in treating opioid-induced constipation in patients with chronic malignant or non-malignant pain.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral naloxone twice daily. Each patient receives an escalating dose until the minimum effective dose or the maximum dose allowed is reached. The minimum effective dose is defined as the dose at which a patient has at least 4 bowel movements within 7 days. Patients receive the minimum effective dose for 7 days and then continue long-term treatment for a maximum of 72 weeks. Patients receiving the maximum dose allowed with fewer than 4 bowel movements per week will discontinue study therapy.

PROJECTED ACCRUAL: Approximately 600 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Moderate to severe opioid-induced constipation; Previously enrolled on protocols NAL-0396, NAL-0397, and/or NAL-0398 OR Low frequency of bowel movements, defined as fewer than 3 per week during the past 2 weeks, AND either of the following: Score of "some", "quite a bit", or "very much" on the constipation distress scale; Laxative or enema dependence
• Daily opioid intake equivalent to at least 30 mg of oral morphine for chronic pain of malignant or non-malignant origin; Stable dose of opioid analgesic agent for at least 2 weeks
• No score of "excruciating" on verbal pain scale
• No history of partial or complete bowel obstruction
• No constipation secondary to factors other than opioids (e.g., autonomic neuropathy or intra-abdominal adhesions)

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Concurrent chemotherapy allowed provided patient has completed at least 1 course prior to study
• Endocrine therapy: Concurrent hormonal therapy allowed provided dosage is stable for at least 2 weeks prior to study
• Radiotherapy: No concurrent palliative radiotherapy to spine, abdomen, or pelvic area
• Surgery: Not specified
• Other: At least 30 days since other investigational drug

--Patient Characteristics--

• Age: Over 18
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Potassium normal
• Other: No uncontrolled endocrinopathy or diabetes; No psychiatric disorder or encephalopathy that would preclude study; No clinically significant medical conditions that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Nathaniel Katz,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000068671; DFCI-NAL-0597; BWH-1999-P-002415/10; BWH-97-08658; ROXANE-NAL-0597
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020605
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08