NCT01367600

Brief Summary

This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

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

February 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
6.3 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

2 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 continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

    3 months

Secondary Outcomes (2)

  • Change from baseline in pain scores

    3 months

  • Number of patients with opioid withdrawal symptoms

    3 months

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: SC Methylnaltrexone (MNTX)

Interventions

SC Methylnaltrexone (MNTX)DRUG
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
  • Negative pregnancy test

You may not qualify if:

  • Women who are pregnant and/or nursing
  • Any concurrent experimental drug therapy
  • Evidence of fecal impaction
  • Clinically significant active diverticular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals

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

February 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)