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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 with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 150 mg | Experimental |
| |
| 300 mg | Experimental |
| |
| 450 mg | Experimental |
| |
| 600 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-methylnaltrexone bromide (MOA-728) | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo: placebo |
| FG001 | 150 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Other | placebo |
|
| 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 |
| FG002 |
| 300 mg |
N-methylnaltrexone bromide (MOA-728): Oral |
| FG003 | 450 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| FG004 | 600 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo: placebo |
| BG001 | 150 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| BG002 | 300 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| BG003 | 450 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| BG004 | 600 mg | N-methylnaltrexone bromide (MOA-728): Oral |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Posted | Count of Participants | Participants | 6 hours |
|
|
|
6 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 | 15 | 33 | 0 | 33 | 10 | 33 |
| EG001 | 150 mg | N-methylnaltrexone bromide (MOA-728): Oral | 3 | 7 | 0 | 7 | 3 | 7 |
| EG002 | 300 mg | N-methylnaltrexone bromide (MOA-728): Oral | 4 | 14 | 0 | 14 | 4 | 14 |
| EG003 | 450 mg | N-methylnaltrexone bromide (MOA-728): Oral | 13 | 33 | 1 | 33 | 9 | 33 |
| EG004 | 600 mg | N-methylnaltrexone bromide (MOA-728): Oral | 18 | 35 | 3 | 35 | 6 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Lymphedema | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cellulitis staphyloccocal | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | 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 |
| |
| Herpes zoster | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
| 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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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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| Male |
|
| Within 2 hours of 1st dose |
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| Within 3 hours of 1st dose |
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| Within 4 hours of 1st dose |
|
| Within 6 hours of 1st dose |
|