Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00605644
• Collaborator: Progenics Pharmaceuticals, Inc. (Industry)
• Enrollment: 128
• Arms: 5
• Duration (Months): 4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: MOA-728; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo
Experimental: 150 mg MOA-728	Drug: MOA-728; Oral Capsules
Experimental: 300 mg MOA-728	Drug: MOA-728; Oral Capsules
Experimental: 450 mg MOA-728	Drug: MOA-728; Oral Capsules
Experimental: 600 mg MOA-728	Drug: MOA-728; Oral Capsules

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment [3 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bausch Health Americas, Inc.
• Progenics Pharmaceuticals, Inc.

Investigators

• Study Director: Jeff Cohn, Bausch Health Americas, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT00605644
• Other Study ID Numbers: 3200A3-2202
• First Posted: Jan 31, 2008
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Constipation

Study Results

Participant Flow

Arm/Group Title	Placebo	150 mg	300 mg	450 mg	600 mg
Arm/Group Description	Placebo Placebo: Placebo	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules
Period Title: Overall Study
STARTED	29	19	20	30	30
COMPLETED	28	18	18	25	22
NOT COMPLETED	1	1	2	5	8

Baseline Characteristics

Arm/Group Title	Placebo	150 mg	300 mg	450 mg	600 mg	Total
Arm/Group Description	Placebo Placebo: Placebo	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	Total of all reporting groups
Overall Participants	29	19	20	30	30	128
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.24 (10.45)	54.68 (9.49)	51.25 (12.72)	50.17 (10.46)	49.13 (8.59)	51.69 (10.38)
Sex: Female, Male (Count of Participants)
Female	18 62.1%	9 47.4%	10 50%	18 60%	22 73.3%	77 60.2%
Male	11 37.9%	10 52.6%	10 50%	12 40%	8 26.7%	51 39.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	150 mg	300 mg	450 mg	600 mg
Arm/Group Description	Placebo Placebo: Placebo	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules	MOA-728 MOA-728: Oral Capsules
Measure Participants	29	19	20	30	30
Count of Participants [Participants]	2 6.9%	3 15.8%	2 10%	5 16.7%	6 20%

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Placebo		150 mg		300 mg		450 mg		600 mg
Arm/Group Description	Placebo Placebo: Placebo		MOA-728 MOA-728: Oral Capsules		MOA-728 MOA-728: Oral Capsules		MOA-728 MOA-728: Oral Capsules		MOA-728 MOA-728: Oral Capsules
All Cause Mortality
	Placebo		150 mg		300 mg		450 mg		600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		150 mg		300 mg		450 mg		600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/19 (0%)		0/20 (0%)		1/30 (3.3%)		2/30 (6.7%)
Gastrointestinal disorders
Constipation	0/29 (0%)		0/19 (0%)		0/20 (0%)		0/30 (0%)		1/30 (3.3%)
Nausea	0/29 (0%)		0/19 (0%)		0/20 (0%)		0/30 (0%)		1/30 (3.3%)
Vomiting	0/29 (0%)		0/19 (0%)		0/20 (0%)		0/30 (0%)		1/30 (3.3%)
Nervous system disorders
Syncope	0/29 (0%)		0/19 (0%)		0/20 (0%)		0/30 (0%)		1/30 (3.3%)
Vascular disorders
Arteriosclerosis	0/29 (0%)		0/19 (0%)		0/20 (0%)		1/30 (3.3%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		150 mg		300 mg		450 mg		600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/29 (13.8%)		3/19 (15.8%)		9/20 (45%)		12/30 (40%)		6/30 (20%)
Gastrointestinal disorders
Abdominal pain	1/29 (3.4%)		0/19 (0%)		0/20 (0%)		4/30 (13.3%)		2/30 (6.7%)
Diarrhea	0/29 (0%)		0/19 (0%)		1/20 (5%)		1/30 (3.3%)		1/30 (3.3%)
Dyspepsia	0/29 (0%)		0/19 (0%)		1/20 (5%)		1/30 (3.3%)		0/30 (0%)
Haemorrhoid	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Nausea	0/29 (0%)		1/19 (5.3%)		1/20 (5%)		2/30 (6.7%)		2/30 (6.7%)
Vomiting	0/29 (0%)		1/19 (5.3%)		1/20 (5%)		2/30 (6.7%)		1/30 (3.3%)
Pyrexia	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Infections and infestations
Oral candidiasis	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Injury, poisoning and procedural complications
Joint sprain	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Investigations
Band neutrophil count increased	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
White blood cell count increased	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Metabolism and nutrition disorders
Food craving	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Hyperglycaemia	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Musculoskeletal and connective tissue disorders
Neck pain	2/29 (6.9%)		0/19 (0%)		0/20 (0%)		1/30 (3.3%)		0/30 (0%)
Nuchal rigidity	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Nervous system disorders
Dizziness	0/29 (0%)		1/19 (5.3%)		0/20 (0%)		0/30 (0%)		0/30 (0%)
Headache	1/29 (3.4%)		2/19 (10.5%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Psychiatric disorders
Anxiety	0/29 (0%)		1/19 (5.3%)		0/20 (0%)		0/30 (0%)		0/30 (0%)
Reproductive system and breast disorders
Pelvic pain	0/29 (0%)		0/19 (0%)		1/20 (5%)		0/30 (0%)		0/30 (0%)
Vascular disorders
Orthostatic hypertension	0/29 (0%)		0/19 (0%)		1/20 (5%)		1/30 (3.3%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.