Open-Label Treatment Extension of Protocol MNTX 301

Bausch Health Americas, Inc.27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Terminal Illness

Interventions

SC Methylnaltrexone (MNTX)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Progenics Pharmaceuticals

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Number of patients with adverse events

To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Time frame: 3 months

Secondary Outcomes

Change from baseline in pain scores

To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Time frame: 3 months

Number of patients with opioid withdrawal symptoms

To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Time frame: 3 months

Data from ClinicalTrials.gov

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