A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation
| Autor: | Kunwar Shailubhai, Blas Prieto, Marianela De La Portilla, Philip B. Miner, Gregory J Wiener, William Koltun, Patrick Griffin, Laura Barrow, Mary Beth Layton, Leslie Magnus |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Constipation Gastroenterology law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine medicine In patient Functional GI Disorders Gastrointestinal agent Hepatology business.industry Clinical trial chemistry 030220 oncology & carcinogenesis Physical therapy Plecanatide Defecation 030211 gastroenterology & hepatology medicine.symptom business Uroguanylin |
| Zdroj: | The American Journal of Gastroenterology |
| ISSN: | 0002-9270 |
| DOI: | 10.1038/ajg.2016.611 |
| Popis: | Objectives: This study assessed the efficacy and safety of plecanatide, a guanylate cyclase-C (GC-C) agonist and the first uroguanylin analog approved for the treatment of chronic idiopathic constipation (CIC). Methods: This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC. Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks. The primary efficacy endpoint was the percentage of patients who were durable overall complete spontaneous bowel movement (CSBM) responders over the 12-week treatment period. Patients were instructed to record their daily bowel movements, stool consistency scores, and abdominal symptoms in an electronic diary. Treatment-emergent adverse events (AEs) were collected. Results: Each dose of plecanatide resulted in a significantly greater percentage of durable overall CSBM responders (21.0%, 3 mg; 19.5%, 6 mg) as compared with placebo (10.2% P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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