Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	Over 18	Pharmaceutical / Industry	DFCI-NAL-0597 BWH-1999-P-002415/10, BWH-97-08658, ROXANE-NAL-0597, NCT00020605

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.

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

Expected Enrollment

Approximately 600 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Nathaniel Katz, MD, Protocol chair		Ph: 617-632-3474; 866-790-4500

Registry Information
Official Title		A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase IIB Study of Oral Naloxone for the Treatment of Opioid-Induced Constipation in Patients with Chronic, Non-malignant Pain or Malignant Pain
Trial Start Date		2000-05-23
Registered in ClinicalTrials.gov		NCT00020605
Date Submitted to PDQ		2001-04-16
Information Last Verified		2001-10-01
NCI Grant/Contract Number		P30-CA06516

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