Open-Label Treatment Extension of Protocol MNTX 301

Terminal Illness Clinical Trial

Official title:

A Three-Month Open-Label Treatment Extension of Protocol MNTX 301

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367600
• Other study ID #: MNTX 301EXT
• Status: Completed
• Phase: Phase 3
• Start date: February 2003
• Est. completion date: February 2005

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment

2. Negative pregnancy test

Exclusion Criteria:

1. Women who are pregnant and/or nursing

2. Any concurrent experimental drug therapy

3. Evidence of fecal impaction

4. Clinically significant active diverticular disease

Related Conditions & MeSH terms

• Terminal Illness

Intervention

Drug:
• SC Methylnaltrexone (MNTX)

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals	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 continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.	3 months
Secondary	Change from baseline in pain scores	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.	3 months
Secondary	Number of patients with opioid withdrawal symptoms	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.	3 months