Open-Label Treatment Extension of Protocol MNTX 302

A Three-Month Open-Label Treatment Extension of Protocol MNTX 302

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367613

Enrollment

Registered

2011-06-07

Start date

2004-03-31

Completion date

2006-01-31

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

Interventions

DRUGSC Methylnaltrexone

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. 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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with adverse events	3 months	To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026