Open-Label Treatment Extension of Protocol MNTX 301

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Terminal Illness

Treatments: Drug: SC Methylnaltrexone (MNTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367600

MNTX 301EXT

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone (MNTX)