CompletedNCT00547586Updated Aug 20, 2020Results posted

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

A Phase 2 interventional study of N-methylnaltrexone bromide (MOA-728) and placebo in Constipation, sponsored by Bausch Health Americas, Inc.. Completed at 41 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 122
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Constipation

Browse trials for

Constipation 1,018

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 122 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 122 participants (actual)

Study arms

Placebo comparator
Placebo
Other: placebo
Experimental
150 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Experimental
300 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Experimental
450 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Experimental
600 mg
Drug: N-methylnaltrexone bromide (MOA-728)

Interventions

DrugN-methylnaltrexone bromide (MOA-728)
Oral
Otherplacebo
placebo

What researchers measure

Primary outcomes

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Time frame: 6 hours

Results

Posted Aug 20, 2020

Participant flow

Participant flow — Overall Study
Milestone	Placebo	150 mg	300 mg	450 mg	600 mg
Started	33	7	14	33	35
Completed	28	6	13	27	32
Not completed	5	1	1	6	3

Outcome measures

PrimaryPercentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment

Time frame:: 6 hours
Reported as:: Count of participants · Participants

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Participants	Placebo	150 mg	300 mg	450 mg	600 mg
Within 1 hour of 1st dose	0	0	0	7	2
Within 2 hours of 1st dose	1	1	1	9	5
Within 3 hours of 1st dose	3	1	2	13	9
Within 4 hours of 1st dose	3	1	4	15	14
Within 6 hours of 1st dose	6	1	4	15	17

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	15/33 (45.5%)	0/33 (0%)	10/33 (30.3%)
150 mg	3/7 (42.9%)	0/7 (0%)	3/7 (42.9%)
300 mg	4/14 (28.6%)	0/14 (0%)	4/14 (28.6%)
450 mg	13/33 (39.4%)	1/33 (3%)	9/33 (27.3%)
600 mg	18/35 (51.4%)	3/35 (8.6%)	6/35 (17.1%)

Most frequent serious events

Most frequent serious events
Event	Placebo	150 mg	300 mg	450 mg	600 mg
Accidental overdoseInjury, poisoning and procedural complications	0/33	0/7	0/14	1/33	0/35
LymphedemaGeneral disorders	0/33	0/7	0/14	0/33	1/35
PainGeneral disorders	0/33	0/7	0/14	0/33	1/35
Cellulitis staphyloccocalInfections and infestations	0/33	0/7	0/14	0/33	1/35
Bursitis infectiveInfections and infestations	0/33	0/7	0/14	0/33	1/35
OverdoseInjury, poisoning and procedural complications	0/33	0/7	0/14	0/33	1/35
Small intestinal obstructionGastrointestinal disorders	0/33	0/7	0/14	0/33	1/35

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Placebo	150 mg	300 mg	450 mg	600 mg
Abdominal discomfortGastrointestinal disorders	0/33	1/7	0/14	0/33	0/35
Abdominal painGastrointestinal disorders	0/33	0/7	2/14	2/33	1/35
DiarrheaGastrointestinal disorders	0/33	1/7	0/14	2/33	2/35
NauseaGastrointestinal disorders	3/33	1/7	1/14	1/33	1/35
Herpes zosterInfections and infestations	0/33	1/7	0/14	0/33	0/35
Tooth fractureInjury, poisoning and procedural complications	0/33	1/7	0/14	0/33	0/35
Bone painMusculoskeletal and connective tissue disorders	0/33	1/7	0/14	0/33	0/35
FlatulenceGastrointestinal disorders	2/33	0/7	1/14	0/33	0/35
Gastrointestinal motility disorderGastrointestinal disorders	0/33	0/7	1/14	0/33	0/35
Urinary tract infectionInfections and infestations	1/33	0/7	1/14	0/33	1/35

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	150 mg	300 mg	450 mg	600 mg	Total
Mean	48 ± 8.75	48.43 ± 6.80	52.43 ± 8.56	51.21 ± 12.24	49.51 ± 11.25	49.84 ± 10.39

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	150 mg	300 mg	450 mg	600 mg	Total
Female	22	5	5	24	18	74
Male	11	2	9	9	17	48

Study locations

41 sites

Mobile, Alabama 36608, United States
Litchfield Park, Arizona 85340, United States
Tucson, Arizona 85710, United States
Tucson, Arizona 85741, United States
Hot Springs, Arkansas 71901, United States
Hot Springs, Arkansas 71903, United States
Garden Grove, California 92843, United States
Long Beach, California 90813, United States
Los Angeles, California 90048, United States
Murrieta, California 30060, United States
San Diego, California 92121, United States
Chiefland, Florida 32626, United States
Jacksonville, Florida 32216, United States
Jupiter, Florida 33458, United States
Largo, Florida 33770, United States
Naples, Florida 34104, United States
Ocala, Florida 34471, United States
Ormond Beach, Florida 32174, United States
Spring Hill, Florida 34609, United States
Chicago, Illinois 60610, United States
Indianapolis, Indiana 46250, United States
Sunset, Louisiana 70584, United States
Elkridge, Maryland 21075, United States
Brockton, Massachusetts 2301, United States
Cadillac, Michigan 49601, United States
Traverse City, Michigan 49684, United States
Biloxi, Mississippi 39531, United States
Ocean Springs, Mississippi 39564, United States
Las Vegas, Nevada 89119, United States
Albuquerque, New Mexico 87102, United States
Charlotte, North Carolina 28204, United States
Winston-Salem, North Carolina 27103, United States
Dayton, Ohio 45439, United States
Toledo, Ohio 43623, United States
Medford, Oregon 97504, United States
Chattanooga, Tennessee 37404, United States
Beaumont, Texas 77701, United States
Colleyville, Texas 76034, United States
Dallas, Texas 75230, United States
San Antonio, Texas 78229, United States
Alexandria, Virginia 22304, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00547586
Lead sponsor: Bausch Health Americas, Inc.
Collaborators: Progenics Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Oct 22, 2007
Start date: Oct 2007
Primary completion: Feb 2008
Completion: Feb 2008
Results posted: Aug 20, 2020
Last update: Aug 20, 2020

Study contacts

Medical Monitor

study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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