Study Completed

Heartburn

Bayer Identifier:

11201

ClinicalTrials.gov Identifier:

NCT01928888

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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

May 2003 - February 2004

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Talcid (Hydrotalcite, BAY4516H)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Frankfurt, 60596, Germany
Completed		Leipzig, 04107, Germany
Completed		Berlin, 10437, Germany
Completed		Dresden, 01307, Germany

Primary Outcome

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.
Time Frame:
up to 60 minutes
Safety Issue:
No

Secondary Outcome

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.
Time Frame:
up to 30 min
Safety Issue:
No
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.
Time Frame:
up to 3 h
Safety Issue:
No

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

Additional Information

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