Clinical trial NCT01928888: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Keywords: Acute heartburn episodes
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Total heartburn relief over 0-60 min
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine
timeFrame: up to 30 min
measure: Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine
timeFrame: up to 3 h
Other outcomes:
Locations:
city: Frankfurt
country: Germany
state: Hessen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: ask Central Contact
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: