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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020605
First received: July 11, 2001
Last updated: May 9, 2009
Last verified: October 2001
  Purpose

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 Intervention Phase
Constipation, Impaction, and Bowel Obstruction
Unspecified Adult Solid Tumor, Protocol Specific
Drug: naloxone hydrochloride
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
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.

  Eligibility

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00020605

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Nathaniel Katz, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00020605     History of Changes
Other Study ID Numbers: CDR0000068671, DFCI-NAL-0597, BWH-1999-P-002415/10, BWH-97-08658, ROXANE-NAL-0597
Study First Received: July 11, 2001
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
constipation, impaction, and bowel obstruction

Additional relevant MeSH terms:
Constipation
Fecal Impaction
Intestinal Obstruction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Naloxone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014