Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

NCT00547586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-08-20

Study results available
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Summary

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Conditions

Interventions

DRUG

N-methylnaltrexone bromide (MOA-728)

Oral

OTHER

placebo

placebo

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547586 on ClinicalTrials.gov