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OpenTrials
Completed

NCT Number: NCT01367561

Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

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.

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Key information

Conditions

Healthy Males

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males, 18 to 65 yrs with normal urinary function
  • Body weight less than 150 kg and Body Mass Index between 20-32.

Exclusion criteria

  • Females
  • History of drug or alcohol abuse
  • History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.)
  • Subjects who received opioids for one week or longer in the last 2 months.

Treatment and study plan

naloxone

Drug

IV Methylnaltrexone (MNTX)

Drug

Placebo

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jun 7, 2011
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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