Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01367561
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Males	Drug: Naloxone; Drug: IV Methylnaltrexone (MNTX); Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: May 1, 2003
• Actual Study Completion Date: May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Naloxone
Experimental: Arm 2	Drug: IV Methylnaltrexone (MNTX)
Placebo Comparator: Arm 3	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01367561
• Other Study ID Numbers: MNTX 206
• First Posted: Jun 7, 2011
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Naloxone; Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019