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

NCT00936884 | Completed Phase 3 Results

• 2 other identifiers: 3200K1-3361B2541004
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 6

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.

Conditions

Constipation

Keywords

Opioid Induced Constipation

Outcome Measures

Primary Outcomes (2)

• The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection.

  There were 2 co-primary endpoints for this study. This measurement is the first of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups. To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction). Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only. Therefore, no efficacy results are presented for the open-label period.

  Up to 4 hours after the first injection

• The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period.

  This measurement is the second of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint).

  Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period

Secondary Outcomes (1)

• Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration.

  Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period

Study Arms (3)

Methylnaltrexone double-blind

EXPERIMENTAL

Methylnaltrexone once every other day.

Drug: Methylnaltrexone

Placebo

PLACEBO COMPARATOR

Placebo once every other day.

Drug: Placebo

Methylnaltrexone open-label

OTHER

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.

Drug: Methylnaltrexone

Interventions

Methylnaltrexone 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).

Also known as: MOA-728, MNTX

Methylnaltrexone double-blind; Methylnaltrexone open-label

Placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (6)

Unknown Facility

Koyang-shi, Kyounggi-do, 410-719, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, 152-703, South Korea

Location

Unknown Facility

Tainan, 70428, Taiwan

Location

Unknown Facility

Taipei TOC, 100, Taiwan

Location

MeSH Terms

Conditions

Constipation; Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: David Sorscher
• Organization: Salix Pharmaceuticals

david.sorscher@salix.com

919-862-1827

Study Officials

• Enoch Bortey

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Locations

KR (4); TW (2)