title: Randomized clinical trial: a controlled pilot trial of the 5-HT4 receptor agonist revexepride in patients with symptoms suggestive of gastroparesis.
abstract: BACKGROUND
  Gastroparesis is a chronic gastric disorder characterized by delayed gastric emptying without mechanical obstruction, and clinical symptoms as postprandial fullness, early satiety, bloating, nausea, vomiting, and abdominal pain. Prokinetic agents are used for the treatment of gastroparesis. Revexepride, a 5-hydroxytryptamine (serotonin) receptor (5-HT4 R) agonist, could be a good candidate drug for the gastroparesis treatment.
  
  
  OBJECTIVE
  In the current phase II, exploratory, double-blind, randomized, stratified, placebo-controlled, repeated dose trial (EudraCT number 2007-004997-23), the efficacy on gastrointestinal symptoms and gastric emptying rate, safety, and pharmacokinetic profile of three oral doses of revexepride (0.02, 0.1, and 0.5 mg administered orally t.i.d. for 4 weeks) was evaluated in trial participants (diabetic and non-diabetic) with upper gastrointestinal tract symptoms suggestive for gastroparesis.
  
  
  METHODS
  Eighty participants, enrolled in four parallel treatment groups, were asked to score their symptom diary data, gastroparesis cardinal symptom index (GCSI), patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM), quality of life questionnaires, and meal-related symptom score. Gastric emptying rate was evaluated by (13) C-octanoic acid breath test.
  
  
  RESULTS
  The severity of the symptoms assessed by means of GCSI and PAGI-SYM decreased at Week 2 and decreased further at Week 4 in all treatment groups including placebo, with similar trends in all treatment groups. Quality of life improved in all treatment groups after 4 weeks of treatment. No differences on gastric emptying rate were shown between any of the active treatment groups and placebo. Revexepride was generally safe and well-tolerated.
  
  
  CONCLUSIONS
  Four weeks of revexepride treatment did not improve symptoms or gastric emptying over placebo in patients with symptoms suggestive of gastroparesis.
authors.affiliation: TARGID, University of Leuven, Leuven, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Tack
authors.affiliation: TARGID, University of Leuven, Leuven, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Rotondo
authors.affiliation: Shire-Movetis NV, Turnhout, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Meulemans
authors.affiliation: Shire-Movetis NV, Turnhout, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Thielemans
authors.affiliation: Shire-Movetis NV, Turnhout, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Cools
mesh_terms: D001572:Benzofurans / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D018589:Gastroparesis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D058828:Serotonin 5-HT4 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011795:Surveys and Questionnaires
chemical_list: D001572:Benzofurans; D058828:Serotonin 5-HT4 Receptor Agonists; C000600233:revexepride
keywords: 5-HT4 receptor; gastric emptying; gastroparesis