Open-Label Treatment Extension of Protocol MNTX 301

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367600

Enrollment

Registered

2011-06-07

Start date

2003-02-28

Completion date

2005-02-28

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Terminal Illness

Keywords

Advanced medical illness

Brief summary

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

Interventions

DRUGSC Methylnaltrexone (MNTX)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with adverse events	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Secondary

Measure	Time frame	Description
Change from baseline in pain scores	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.
Number of patients with opioid withdrawal symptoms	3 months	To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026