Open-Label Treatment Extension of Protocol MNTX 302

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Terminal Illness

Treatments: Drug: SC Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367613

MNTX 302EXT

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone