NCT01367561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 27, 2011

Last Update Submit

April 11, 2023

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Naloxone

Arm 2

EXPERIMENTAL
Drug: IV Methylnaltrexone (MNTX)

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NaloxoneDRUG
Arm 1
IV Methylnaltrexone (MNTX)DRUG
Arm 2
PlaceboDRUG
Arm 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

Naloxonemethylnaltrexone

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

October 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)