This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

This study has been completed.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
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 Intervention Phase
Healthy Males Drug: Naloxone Drug: IV Methylnaltrexone (MNTX) Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Maximal force of detrusor contraction (Pdet) after administration of MNTX [ Time Frame: 14 days ]
    To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.

Enrollment: 15
Study Start Date: October 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Naloxone
Experimental: Arm 2 Drug: IV Methylnaltrexone (MNTX)
Placebo Comparator: Arm 3 Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01367561

United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc. Identifier: NCT01367561     History of Changes
Other Study ID Numbers: MNTX 206
Study First Received: May 27, 2011
Last Updated: July 18, 2011

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 19, 2017