Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study
| Autor: | Kei Matsueda, Ken Haruma, Yoshihiro Nakashima, H Hayase, Motoko Ida, Shin Fukudo, Hiraku Akiho, Michio Hongo |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Diarrhea medicine.medical_specialty Abdominal pain Constipation Physiology Phases of clinical research Placebo Gastroenterology Ramosetron Irritable Bowel Syndrome 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Internal medicine medicine Clinical endpoint Humans Irritable bowel syndrome Endocrine and Autonomic Systems business.industry Middle Aged medicine.disease Abdominal Pain Treatment Outcome chemistry 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Benzimidazoles Female Serotonin Antagonists medicine.symptom business |
| Zdroj: | Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society. 29(6) |
| ISSN: | 1365-2982 |
| Popis: | BACKGROUND Previous studies showed that 5 μg of ramosetron, a serotonin (5-hydroxytryptamine: 5-HT)-3 receptor antagonist, is only effective in male patients with irritable bowel syndrome (IBS) with diarrhea (IBS-D). We hypothesized that either dose 1.25, 2.5, or 5 μg of ramosetron would be effective in female patients with IBS-D. METHODS This randomized, double-blind, placebo-controlled, phase II dose-finding exploratory trial included 409 female outpatients with IBS-D treated in Japan. They were administered oral placebo (n=102), or 1.25 μg (n=104), 2.5 μg (n=104), or 5 μg (n=99) of ramosetron once daily for 12 weeks after a 1-week baseline period. The primary endpoint was monthly responder rates of global improvement of IBS symptoms in the first month. Secondary endpoints included global improvement in the other months, abdominal pain/discomfort, weekly mean changes in the Bristol Stool Form Scale (BSFS), and IBS-QOL. KEY RESULTS Middle dose (2.5 μg) of ramosetron significantly improved abdominal pain/discomfort at second month (62.5%, P=.002), third month (60.6%, P=.005), and the last evaluation point (63.5%, P=.002) and weekly BSFS (P |
| Databáze: | OpenAIRE |
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