Clinical Trial: Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Refl

Brief Summary: This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and tolerability of oral AFQ056 in GERD patients.
  • Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.
  • Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence
  • Validation of the reflux model used in this study using baclofen as positive control.
  • Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 21, 2006
Date Started: August 2006
Date Completion:
Last Updated: June 21, 2007
Last Verified: June 2007