Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Digestive System Diseases

Rare Diseases

Constipation

Chronic Pain

Pain

Opioid-Induced Constipation

Intestinal Obstruction

Signs and Symptoms, Digestive

Intestinal Diseases

Gastrointestinal Diseases

Chronic Graft Versus Host Disease

Narcotic Antagonists

All Drugs and Chemicals

Analgesics

Central Nervous System Depressants

Naloxone

Analgesics, Opioid

Narcotics

naloxone hydrochloride

Nathaniel Katz, MD

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.

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.

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

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

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Oxycodone

OxyCodone Naloxone controlled release tablet

Oxycodone Naloxone PR Tablet taken twice daily

Oxycodone Naloxone

Oxycodone PR Tablets

The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

Eligible patients with documented cancer or non-cancer pain, either currently receiving a WHO step II opioid and requiring the initiation of a WHO step III opioid or currently receiving a WHO step III opioid, and having opioid-related constipation defined by either a KESS score ≥9 or the current use of laxatives (≥3 times per week), will be randomly assigned to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain: cancer or non-cancer.

Any patient having completed the study and wishing to receive OXN PR afterwards may enter an optional open extension phase. During this phase, all patients will receive OXN PR and be managed as per the usual practice in the center until commercial OXN PR is available in France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.

Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study

Mundipharma SAS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain	NCT00020605	Constipation, I... Unspecified Adu...	naloxone hydroc...	18 Years - 120 Years	National Cancer Institute (NCI)
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain	NCT00020605	Constipation, I... Unspecified Adu...	naloxone hydroc...	18 Years - 120 Years	National Cancer Institute (NCI)
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients	NCT01014559	Constipation Pain	Oxycodone Nalox... Oxycodone PR Ta...	18 Years -	Mundipharma SAS

Spots Global Cancer Trial Database for naloxone hydrochloride