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Withdrawn [This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.](streamdown:incomplete-link)
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Active Drug | Experimental | Methylnaltrexone |
|
| Group 2 Non-Active Drug | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylnaltrexone | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Cohn | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Laguna Hills | California | 92637 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
|
|
| Lancaster |
| California |
| 93534 |
| United States |
| Pfizer Investigational Site | Flat Rock | North Carolina | 28731 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Pfizer Investigational Site | Villejuif | 94804 | France |
| Pfizer Investigational Site | El Palmar | Murcia/Spain | 30120 | Spain |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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