NCT01367561CompletedPhase 1
A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers
Bausch Health Americas, Inc.1 site in 1 country15 target enrollmentStarted: October 2002Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Maximal force of detrusor contraction (Pdet) after administration of MNTX
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Arm 2
Experimental
Intervention: IV Methylnaltrexone (MNTX) (Drug)
Arm 3
Placebo Comparator
Intervention: Placebo (Drug)
Arm 1
Experimental
Intervention: Naloxone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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