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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01928888

Enrollment

559

Registered

2013-08-27

Start date

2003-05-31

Completion date

2004-02-29

Last updated

2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heartburn

Keywords

Acute heartburn episodes

Brief 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.

Interventions

DRUGTalcid (Hydrotalcite, BAY4516H)

2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

DRUGFamotidine

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

DRUGPlacebo

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total heartburn relief over 0-60 min	up to 60 minutes	The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.

Secondary

Measure	Time frame	Description
Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine	up to 30 min	The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine	up to 3 h	The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026