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Sponsored by: |
Progenics Pharmaceuticals, Inc. |
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Information provided by: | Progenics Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00401375 |
To evaluate the safety and efficacy of MNTX in patients who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
Condition | Intervention | Phase |
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Post-Operative Ileus (POI) |
Drug: Methylnaltrexone |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Selected Inclusion Criteria:
Selected Exclusion Criteria:
Study ID Numbers: | MNTX 3301 |
Study First Received: | November 16, 2006 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00401375 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Intestinal Obstruction Ileus Digestive System Diseases Bromides Gastrointestinal Diseases Narcotic Antagonists |
Naltrexone Methylnaltrexone Narcotics Peripheral Nervous System Agents Intestinal Diseases |
Gastrointestinal Diseases Narcotic Antagonists Physiological Effects of Drugs Intestinal Diseases Pharmacologic Actions Intestinal Obstruction Ileus |
Digestive System Diseases Sensory System Agents Therapeutic Uses Naltrexone Methylnaltrexone Peripheral Nervous System Agents Central Nervous System Agents |