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

Primary Purpose

Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
naloxone hydrochloride
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation, Impaction, and Bowel Obstruction focused on measuring unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) 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 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

Sites / Locations

  • Brigham and Women's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
December 12, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020605
Brief Title
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2001
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naloxone hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Katz, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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