Open-Label Treatment Extension of Protocol MNTX 302

Terminal Illness Clinical Trial

Official title:

A Three-Month Open-Label Treatment Extension of Protocol MNTX 302

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367613
• Other study ID #: MNTX 302EXT
• Status: Completed
• Phase: Phase 3
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Negative pregnancy test

3. Stable vital signs

Exclusion Criteria:

1. Women who are pregnant and/or nursing

2. Received any investigational product, other than MNTX, in the past 30 days

3. Evidence of fecal impaction

4. Clinically significant active diverticular disease

Related Conditions & MeSH terms

• Terminal Illness

Intervention

Drug:
• SC Methylnaltrexone

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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