Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Healthy Males Clinical Trial

Official title:

A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367561
• Other study ID #: MNTX 206
• Status: Completed
• Phase: Phase 1
• Start date: October 2002
• Est. completion date: May 2003

Study information

• Verified date: April 2023
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Males

Intervention

Drug:
• Naloxone

• IV Methylnaltrexone (MNTX)

• Placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days