Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Arm 2

Group Type EXPERIMENTAL

IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Naloxone

Intervention Type DRUG

IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes