Efficacy of a Motilin Receptor Agonist (ABT-229) for the Treatment of Gastro-Oesophageal Reflux Disease

Aliment Pharmacol Ther. 2002 Apr;16(4):749-57. doi: 10.1046/j.1365-2036.2002.01218.x.

Abstract

Background: ABT-229 is a potent motilin agonist without significant antibiotic activity. It has been shown to improve gastric emptying in humans and to increase lower oesophageal sphincter pressure in cats.

Aim: To assess the efficacy of four different doses of ABT-229 (1.25 mg, 2.5 mg, 5 mg, 10 mg b.d.) compared to placebo in the treatment of gastro-oesophageal reflux disease, and to determine its safety in patients with gastro-oesophageal reflux disease.

Methods: In a double-blind, multicentre study, 324 patients with heartburn were randomized to receive four different doses of ABT-229 or placebo for 8 weeks. The efficacy was evaluated by Patient Symptom Questionnaire, daily diary, endoscopy and global evaluation of efficacy.

Results: There were no statistically significant improvement scores for any of the ABT-229 treatment groups vs. the placebo group in any of the efficacy parameters. Reflux symptom scores were significantly worse after treatment in the dyspeptic group. ABT-229 appeared to be well tolerated and safe in total daily doses up to 20 mg.

Conclusion: ABT-229 appears to have limited, if any, clinical utility in the treatment of gastro-oesophageal reflux disease.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Erythromycin / analogs & derivatives*
  • Erythromycin / therapeutic use*
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Male
  • Quality of Life
  • Receptors, Gastrointestinal Hormone / agonists*
  • Receptors, Neuropeptide / agonists*
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Receptors, Gastrointestinal Hormone
  • Receptors, Neuropeptide
  • motilin receptor
  • Alemcinal
  • Erythromycin