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
Heartburn
About this trial
This is an interventional treatment trial for Heartburn focused on measuring Acute heartburn episodes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm HFP
Arm HPF
Arm FHP
Arm FPH
Arm PHF
Arm PFH
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid