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.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Famotidine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 559
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10437
  • ask Central Contact, Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
    • Leipzig, Sachsen, Germany, 04107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm HFP; 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo	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
Experimental: Arm HPF; 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine	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
Experimental: Arm FHP; 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo	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
Experimental: Arm FPH; 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid	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
Experimental: Arm PHF; 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine	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
Experimental: Arm PFH; 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Acute heartburn episodes
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Antacids; Histamine H2 Antagonists; Famotidine; Hydrotalcite
• Other Study ID Numbers: 11201 (Registry Identifier: DAIDS ES Registry Number)