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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Heartburn

Intervention / Treatment
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* Drug: Talcid (Hydrotalcite, BAY4516H)
* Drug: Famotidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm HFP<br>1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|
| Experimental: Arm HPF<br>1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|
| Experimental: Arm FHP<br>1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|
| Experimental: Arm FPH<br>1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|
| Experimental: Arm PHF<br>1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|
| Experimental: Arm PFH<br>1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid | Drug: Talcid (Hydrotalcite, BAY4516H)<br>* 2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine<br>Drug: Famotidine<br>* 2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg<br>Drug: Placebo<br>* 2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 3 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute heartburn episodes