Abstract | BACKGROUND: METHODS: A total of 170 patients (128 without IBS and 42 with IBS) with chronic idiopathic constipation (CIC) randomly received a placebo (n=42) or 16μg (n=41), 32μg (n=43), or 48μg (n=44) of lubiprostone daily for 2weeks. KEY RESULTS: There was a statistically significant and dose-dependent increase in change from baseline in the weekly average number of spontaneous bowel movements at week 1 (placebo: 1.5±0.4; 16μg: 2.3±0.4, 32μg: 3.5±0.5; and 48μg: 6.8±1.1, per week, mean±SE; P<0.0001). These primary endpoint results were significant on stratified analysis when patients were limited to those without IBS (P<0.0001). The primary endpoint in patients with IBS treated with 48μg of lubiprostone was significantly better than those given placebo (P=0.0086). Dose dependency was also seen for the secondary efficacy endpoints. Lubiprostone produced no serious side effects. CONCLUSIONS & INFERENCES: Our results suggest that lubiprostone produced a steady and effective improvement in the symptoms of CIC with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population.
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Authors | S Fukudo, M Hongo, H Kaneko, R Ueno |
Journal | Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society
(Neurogastroenterol Motil)
Vol. 23
Issue 6
Pg. 544-e205
(Jun 2011)
ISSN: 1365-2982 [Electronic] England |
PMID | 21303430
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 Blackwell Publishing Ltd. |
Chemical References |
- Chloride Channels
- Placebos
- Lubiprostone
- Alprostadil
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Topics |
- Adult
- Alprostadil
(analogs & derivatives, pharmacology, therapeutic use)
- Asian People
- Chloride Channels
(metabolism)
- Constipation
(drug therapy)
- Defecation
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Irritable Bowel Syndrome
(physiopathology)
- Lubiprostone
- Male
- Middle Aged
- Placebos
- Treatment Outcome
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