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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

NCT01928888 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2014-12-25

No results posted yet for this study

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.

Conditions

  • Heartburn

Interventions

DRUG

Talcid (Hydrotalcite, BAY4516H)

2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

DRUG

Famotidine

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

DRUG

Placebo

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2004-02-29
Completion
2004-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928888 on ClinicalTrials.gov