Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00020605|
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 5, 2004
Last Update Posted : May 12, 2009
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 or disease||Intervention/treatment||Phase|
|Constipation, Impaction, and Bowel Obstruction Unspecified Adult Solid Tumor, Protocol Specific||Drug: naloxone hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Study Start Date :||May 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020605
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Nathaniel Katz, MD||Dana-Farber Cancer Institute|