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Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

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ClinicalTrials.gov Identifier: NCT01367561
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, 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.

Condition or disease Intervention/treatment Phase
Healthy Males Drug: Naloxone Drug: IV Methylnaltrexone (MNTX) Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
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 : October 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367561


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

Responsible Party: Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367561     History of Changes
Other Study ID Numbers: MNTX 206
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Naloxone
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents