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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 150 mg | Experimental | MOA-728 |
|
| 300 mg | Experimental | MOA-728 |
|
| 450 mg | Experimental | MOA-728 |
|
| 600 mg | Experimental | MOA-728 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOA-728 | Drug | Oral Capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Cohn | Bausch Health Americas, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Placebo |
| FG001 | 150 mg | MOA-728 MOA-728: Oral Capsules |
| FG002 | 300 mg | MOA-728 MOA-728: Oral Capsules |
| FG003 | 450 mg | MOA-728 MOA-728: Oral Capsules |
| FG004 | 600 mg | MOA-728 MOA-728: Oral Capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Placebo |
| BG001 | 150 mg | MOA-728 MOA-728: Oral Capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment | Posted | Count of Participants | Participants | 3 hours |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Placebo |
|
| BG002 |
| 300 mg |
MOA-728 MOA-728: Oral Capsules |
| BG003 | 450 mg | MOA-728 MOA-728: Oral Capsules |
| BG004 | 600 mg | MOA-728 MOA-728: Oral Capsules |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
MOA-728 MOA-728: Oral Capsules |
| OG004 | 600 mg | MOA-728 MOA-728: Oral Capsules |
|
|
| 0 |
| 29 |
| 4 |
| 29 |
| EG001 | 150 mg | MOA-728 MOA-728: Oral Capsules | 0 | 19 | 3 | 19 |
| EG002 | 300 mg | MOA-728 MOA-728: Oral Capsules | 0 | 20 | 9 | 20 |
| EG003 | 450 mg | MOA-728 MOA-728: Oral Capsules | 1 | 30 | 12 | 30 |
| EG004 | 600 mg | MOA-728 MOA-728: Oral Capsules | 2 | 30 | 6 | 30 |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Haemorrhoid | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pyrexia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Band neutrophil count increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Food craving | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nuchal rigidity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Orthostatic hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.