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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00414856 |
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease |
Drug: AFQ056 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events |
Estimated Enrollment: | 34 |
Study Start Date: | August 2006 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:
Exclusion Criteria:
History of:
Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:
Hypertension well-controlled with the following:
Other protocol-defined inclusion/exclusion criteria may apply
Belgium | |
Novartis Investigative site | |
Brussels, Belgium | |
France | |
Novartis Investigative site | |
Paris, France | |
Germany | |
Novartis Investigative Site | |
Nuernberg, Germany | |
Switzerland | |
Novartis Investigative site | |
Bern, Switzerland |
Principal Investigator: | Novartis | Investigator site |
Study ID Numbers: | CAFQ056A2108 |
Study First Received: | December 21, 2006 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00414856 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
GERD gastroesophageal reflux disease meal-induced gastroesophageal reflux events |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Baclofen Esophageal Diseases Gastroesophageal Reflux |