Healthy Males Clinical Trial
Official title:
A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers
NCT number | NCT01367561 |
Other study ID # | MNTX 206 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 2002 |
Est. completion date | May 2003 |
Verified date | April 2023 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | May 2003 |
Est. primary completion date | May 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Progenics Pharmaceuticals, Inc. | Tarrytown | New York |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal force of detrusor contraction (Pdet) after administration of MNTX | To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention. | 14 days |
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