Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Phase 1

Completed

• Conditions: Healthy Males
• Interventions: Drug: IV Methylnaltrexone (MNTX); Drug: Placebo; Drug: Naloxone

• Registration Number: NCT01367561
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	IV Methylnaltrexone (MNTX)	-
Arm 3	Placebo	-
Arm 1	Naloxone	-

Primary Outcome Measures

Name	Time	Method
Maximal force of detrusor contraction (Pdet) after administration of MNTX	14 days	To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States