Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Males

Treatments: Drug: IV Methylnaltrexone (MNTX); Drug: Placebo; Drug: Naloxone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367561

MNTX 206

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Naloxone

Arm 2

Experimental group

Treatment:

Drug: IV Methylnaltrexone (MNTX)

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo