NCT01367613

Brief Summary

This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5.4 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

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Terminal Illness

Keywords

Advanced medical illness

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

    3 months

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: SC Methylnaltrexone

Interventions

SC MethylnaltrexoneDRUG
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
  • Negative pregnancy test
  • Stable vital signs

You may not qualify if:

  • Women who are pregnant and/or nursing
  • Received any investigational product, other than MNTX, in the past 30 days
  • Evidence of fecal impaction
  • Clinically significant active diverticular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

March 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)