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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To test the effectiveness of MNTX in advanced illness subjects.
To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 3 | Placebo Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC Methylnaltrexone | Drug | Dose 1 |
| |
| SC Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of SC MNTX compared with placebo in inducing laxation | The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives. | 29 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals, Inc. | Tarrytown | New York | 10591 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31951150 | Derived | Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17. | |
| 27573565 | Derived | Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29. |
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| Drug |
|
| SC Methylnaltrexone | Drug | Dose 2 |
|
| 24815199 | Derived | Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10. |
| 19278178 | Derived | Slatkin N, Thomas J, Lipman AG, Wilson G, Boatwright ML, Wellman C, Zhukovsky DS, Stephenson R, Portenoy R, Stambler N, Israel R. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009 Jan-Feb;7(1):39-46. |