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10.1111/apt.13839

http://scihub22266oqcxt.onion/10.1111/apt.13839
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suck abstract from ncbi


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pmid27910150      Aliment+Pharmacol+Ther 2017 ; 45 (1): 14-26
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  • Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome #MMPMID27910150
  • Whitehead WE; Duffy K; Sharpe J; Nabata T; Bruce M
  • Aliment Pharmacol Ther 2017[Jan]; 45 (1): 14-26 PMID27910150show ga
  • BACKGROUND: ONO-2952 is a novel and selective inhibitor of translocator protein 18 kDa that reduces stress-induced defecation and visceral hyperalgesia in rat models. AIM: To evaluate the efficacy and safety of ONO-2952 in females with irritable bowel syndrome with diarrhoea in an exploratory proof-of-concept study. METHODS: A randomised, double-blind, placebo-controlled study was conducted at 49 US centres. Two hundred subjects with irritable bowel syndrome with diarrhoea (Rome III criteria) were randomised to ONO-2952 20 mg, or 60 mg, or placebo. Subjects recorded irritable bowel syndrome symptoms daily during a 2-week baseline period, the 4-week treatment period and for 4 weeks post-treatment. The co-primary endpoints were change from baseline to week 4 in abdominal pain, stool consistency and stool frequency. RESULTS: Improvements in irritable bowel syndrome symptoms were seen with ONO-2952 over placebo in per-protocol analyses for all three co-primary endpoints, but these did not reach statistical significance at the 5% level. The largest improvement was seen with ONO-2952 60 mg. ONO-2952 was well tolerated with a safety profile similar to that of placebo. Most adverse events were mild or moderate in severity and not treatment related. CONCLUSION: ONO-2952 showed evidence of clinical efficacy in reducing irritable bowel syndrome-related symptoms in female subjects with irritable bowel syndrome with diarrhoea, and further evaluation is, therefore, warranted to assess its potential as a treatment for irritable bowel syndrome with diarrhoea (NCT01844180).
  • |*Receptors, GABA/metabolism[MESH]
  • |Abdominal Pain/diagnosis/drug therapy/metabolism[MESH]
  • |Adult[MESH]
  • |Animals[MESH]
  • |Cyclopropanes/*therapeutic use[MESH]
  • |Diarrhea/*diagnosis/*drug therapy/metabolism[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Heterocyclic Compounds, 4 or More Rings/*therapeutic use[MESH]
  • |Humans[MESH]
  • |Irritable Bowel Syndrome/*diagnosis/*drug therapy/metabolism[MESH]
  • |Middle Aged[MESH]


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