A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia

Neurogastroenterol Motil. 2009 Mar;21(3):272-80. doi: 10.1111/j.1365-2982.2009.01261.x.


Impaired gastric accommodation, hypersensitivity to distension and delayed gastric emptying are major pathophysiological mechanisms in functional dyspepsia (FD). Acotiamide (Z-338) was well-tolerated in healthy volunteers. To determine the effect of three doses of Acotiamide on major pathophysiological mechanisms, symptoms, quality of life (QOL) and safety in functional dyspeptics. A phase IIa, randomized, double-blind, placebo-controlled study (14, 21 and 28 days, respectively, for run-in, study drug administration and follow-up). Gastric accommodation, sensitivity to distension and gastric emptying were assessed by barostat and (13)C breath test, symptoms by daily diary cards and QOL by SF-36. A total of 71 patients were enrolled (62 evaluable). There was no effect on gastric emptying and sensitivity to distension. 300 mg was better than placebo for meal accommodation (P = 0.024). 100 mg was better than placebo at week 2 for upper abdominal bloating (P = 0.001) and overall symptom score (P = 0.022), and at week 3 for bloating (P = 0.008) and heartburn (P = 0.041). 100 mg was also better than placebo for QOL (physical function) (P = 0.003). Acotiamide was safe and well-tolerated in patients with FD. The involved mechanism could at least in part depend on an effect on meal-induced accommodation. 100 mg Acotiamide exhibited the potential to improve FD symptoms and QOL. Further studies are indicated.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Benzamides / pharmacology
  • Benzamides / therapeutic use*
  • Breath Tests
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Dyspepsia / drug therapy*
  • Dyspepsia / physiopathology
  • Female
  • Gastric Emptying / drug effects
  • Gastrointestinal Agents / pharmacology
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Placebos*
  • Quality of Life
  • Thiazoles / pharmacology
  • Thiazoles / therapeutic use*
  • Young Adult


  • Benzamides
  • Gastrointestinal Agents
  • Placebos
  • Thiazoles
  • Z 338