NCT01928888

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heartburn

Interventions

Type	Name	Description
DRUG	Talcid (Hydrotalcite, BAY4516H)	2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
DRUG	Famotidine	2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
DRUG	Placebo	2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2013-08-27
• Last updated: 2014-12-25

Locations

5 sites across 1 country: Germany