NCT00605644

Brief 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 administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

August 20, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

January 18, 2008

Results QC Date

August 8, 2020

Last Update Submit

August 8, 2020

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment

    3 hours

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

150 mg

EXPERIMENTAL

MOA-728

Drug: MOA-728

300 mg

EXPERIMENTAL

MOA-728

Drug: MOA-728

450 mg

EXPERIMENTAL

MOA-728

Drug: MOA-728

600 mg

EXPERIMENTAL

MOA-728

Drug: MOA-728

Interventions

MOA-728DRUG

Oral Capsules

150 mg300 mg450 mg600 mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
  • Taking oral, transdermal, intravenous, or subcutaneous opioids.
  • Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

You may not qualify if:

  • History of chronic constipation before the initiation of opioid therapy.
  • Other GI disorders known to affect bowel transit.
  • Women who are pregnant, breast feeding, or plan to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 20, 2020

Results First Posted

August 20, 2020

Record last verified: 2020-08