Placebo Controlled Phase IV Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid, a Single Dose of Oral Famotidine and a Single Dose of Placebo in Patients With Acute Heartburn Episodes

A Randomized, Double-blind, Three-fold Cross-over, Multi-center Study to Compare the Efficacy and Safety of a Single Dose of Oral Talcid (1000 mg Hydrotalcite), a Single Dose of Oral Famotidine 10 mg, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.

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.

Inclusion Criteria:

• Male or female between the age of 18 to 65 years
• A minimum of 6 months history of heartburn
• History of relief of heartburn episodes after self-medication (OTC use) within at least 2 hours
• Occurrence of heartburn episodes at least twice a week during the previous two months
• Severity of heartburn episodes at least 5 on an 11-category heartburn severity scale

Exclusion Criteria:

• History of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena
• History of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with H2-antagonists or proton pump inhibitors within the previous year
• History of significant gastrointestinal hemorrhage or gastrointestinal surgery
• Gastrointestinal odynophagia (pain during swallowing)
• History or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, Heliobacter pylori gastritis, or cholelithiasis
• Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception