NCT01367600CompletedPhase 3
A Three-Month Open-Label Treatment Extension of Protocol MNTX 301
Bausch Health Americas, Inc.1 site in 1 country27 target enrollmentStarted: February 2003Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Number of patients with adverse events
Study Overview
Brief Summary
This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
- •Negative pregnancy test
Exclusion Criteria
- •Women who are pregnant and/or nursing
- •Any concurrent experimental drug therapy
- •Evidence of fecal impaction
- •Clinically significant active diverticular disease
Arms & Interventions
Arm 1
Experimental
Intervention: SC Methylnaltrexone (MNTX) (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events
Time Frame: 3 months
To provide access to continued treatment with MNTX administered SC, to patients who completed Progenics' MNTX 301.
Secondary Outcomes
- Change from baseline in pain scores(3 months)
- Number of patients with opioid withdrawal symptoms(3 months)
Investigators
Study Sites (1)
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