Abstract | BACKGROUND: AIM: METHODS: In this double-blind, placebo-controlled study, patients were randomly assigned to receive dextofisopam 200 mg b.d. or placebo for 12 weeks. The prospectively defined primary endpoint was number of months of adequate overall relief of IBS symptoms. Bowel function was assessed primarily via stool frequency and consistency. RESULTS: Of 140 enrolled patients, 66 received dextofisopam and 74 placebo; 73% of the patients were women, and 78% had d-IBS. Dextofisopam was superior to placebo on the primary endpoint (P = 0.033). In d-IBS patients treated with dextofisopam, both men and women had improved stool consistency, but stool frequency was reduced only in women. Benefit diminished over time on the primary endpoint, but persisted on frequency and consistency. Dextofisopam and placebo had similar rates and types of adverse events, with more events of worsening abdominal pain with dextofisopam (12% vs. 4%) and more headaches with placebo (12% vs. 5%). Constipation was rare. CONCLUSION:
Dextofisopam should be further evaluated as a new treatment for men and women with d-IBS and a-IBS.
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Authors | S M Leventer, K Raudibaugh, C L Frissora, N Kassem, J C Keogh, J Phillips, A W Mangel |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 27
Issue 2
Pg. 197-206
(Jan 15 2008)
ISSN: 1365-2036 [Electronic] England |
PMID | 17973974
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antidiarrheals
- Placebos
- Benzodiazepines
- tofisopam
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Topics |
- Abdominal Pain
(chemically induced)
- Adult
- Aged
- Antidiarrheals
(therapeutic use)
- Benzodiazepines
(therapeutic use)
- Diarrhea
(drug therapy)
- Double-Blind Method
- Female
- Humans
- Irritable Bowel Syndrome
(drug therapy, physiopathology)
- Male
- Middle Aged
- Patient Satisfaction
- Placebos
- Stereoisomerism
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