Overview

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

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Aluminum Hydroxide
Famotidine
Hydrotalcite
Magnesium Hydroxide
Criteria
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