Trial Condition(s):

Heartburn

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

Bayer Identifier:

11201

ClinicalTrials.gov Identifier:

NCT01928888

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
559
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Talcid (Hydrotalcite, BAY4516H)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04107

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 10437

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 

Trial Design