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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
6
Primary Outcome
- Total heartburn relief over 0-60 minThe total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.Timeframe: up to 60 minutes
Secondary Outcome
- Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidineThe total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.Timeframe: up to 30 min
- Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidineThe total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.Timeframe: up to 3 h
Additional Information
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