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Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation

NCT00936884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-02

Study results available
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Summary

The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

Conditions

Interventions

DRUG

Methylnaltrexone

Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and \< 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and \<38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).

DRUG

Placebo

Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments).

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Enoch Bortey · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

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 NCT00936884 on ClinicalTrials.gov