Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367561
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Salix Pharmaceuticals:

Primary Outcome Measures:
  • Maximal force of detrusor contraction (Pdet) after administration of MNTX [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01367561

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

No publications provided

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367561     History of Changes
Other Study ID Numbers: MNTX 206
Study First Received: May 27, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Naloxone
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014