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

NCT ID: NCT00936884

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-11-30

Brief 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.

Detailed Description

Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.

Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.

All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylnaltrexone double-blind

Methylnaltrexone once every other day.

Group Type: EXPERIMENTAL

Methylnaltrexone

Intervention Type: DRUG

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).

Placebo

Placebo once every other day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects received matching placebo injections.

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

Methylnaltrexone open-label

Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.

Group Type: OTHER

Methylnaltrexone

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

MOA-728; MNTX

Eligibility Criteria

Inclusion Criteria

• Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;
• Is receiving a regular dose of opioids for the control of pain;
• Has a diagnosis of opioid induced constipation;
• Is on a stable laxative regimen.

Exclusion Criteria

• Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
• Has evidence of current fecal impaction;
• Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
• Has a body weight less than 27 kg
• Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enoch Bortey

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Koyang-shi, Kyounggi-do, South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Tainan City, , Taiwan

Taipei TOC, , Taiwan

Countries

South Korea; Taiwan

Other Identifiers

B2541004

Identifier Type: -

Identifier Source: secondary_id

3200K1-3361

Identifier Type: -

Identifier Source: org_study_id