Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Bausch Health Americas, Inc.15 enrolled

Overview

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Males

Interventions

NaloxoneDRUG

IV Methylnaltrexone (MNTX)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy males, 18 to 65 yrs with normal urinary function 2. Body weight less than 150 kg and Body Mass Index between 20-32. Exclusion Criteria: 1. Females 2. History of drug or alcohol abuse 3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.) 4. Subjects who received opioids for one week or longer in the last 2 months.

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Maximal force of detrusor contraction (Pdet) after administration of MNTX

To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.

Time frame: 14 days

Data from ClinicalTrials.gov

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