The purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg Talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. The study is designed to collect more efficacy data on Talcid® in patients using self-medication to relief the symptoms of acute heartburn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
559
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Dresden, Saxony, Germany
Unnamed facility
Leipzig, Saxony, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Ask Central Contact, Germany
Total heartburn relief over 0-60 min
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Time frame: up to 60 minutes
Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Time frame: up to 30 min
Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Time frame: up to 3 h
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