Open-Label Treatment Extension of Protocol MNTX 302

Phase 3CompletedNCT01367613

Bausch Health Americas, Inc.89 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Terminal Illness

Interventions

SC MethylnaltrexoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Number of patients with adverse events

To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

Time frame: 3 months

Data from ClinicalTrials.gov

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