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

Onglets principaux

Masclee, A. Heading, R. Berstad, A. Piessevaux, Hubert [UCL] Popiela, T. Vandenberghe, Alécia [UCL] Tack, Jan

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 C-13 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.

Type de document Article de périodique (Journal article) – Journal Article, Randomized Controlled Trial
Type d'accès Accès restreint
Année de publication 2009
Langue Anglais
Information sur le périodique "Neurogastroenterology and Motility" - Vol. 21, no. 3, p. 272-80 (2009)
Peer reviewed oui
Editeur Wiley-blackwell Publishing, Inc (Malden)
issn 1350-1925
e-issn 1365-2982
Statut de la publication Publié
Affiliations UCL - MD/MINT - Département de médecine interne
UCL - (SLuc) Service d'hépato-gastro-entérologie
UCL - (SLuc) Unité d'oncologie médicale
UCL - MD/BICL - Département de biochimie et de biologie cellulaire
MESH Subject Young Adult ; Thiazoles - pharmacology - therapeutic use ; Quality of Life ; Placebos ; Pilot Projects ; Middle Aged ; Male ; Humans ; Gastrointestinal Agents - pharmacology - therapeutic use ; Gastric Emptying - drug effects ; Female ; Dyspepsia - drug therapy - physiopathology ; Double-Blind Method ; Dose-Response Relationship, Drug ; Breath Tests ; Benzamides - pharmacology - therapeutic use ; Aged ; Adult ; Adolescent
Mots-clés acotiamide ; functional dyspepsia ; gastric accommodation ; gastric emptying ; gastric sensitivity ; Z-338
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Référence bibliographique Masclee, A. ; Heading, R. ; Berstad, A. ; Piessevaux, Hubert ; Popiela, T. ; et. al. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. In: Neurogastroenterology and Motility, Vol. 21, no. 3, p. 272-80 (2009)
Permalien http://hdl.handle.net/2078.1/35786