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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

NCT ID: NCT01928888

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Heartburn

Keywords

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Acute heartburn episodes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm HFP

1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm HPF

1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm FHP

1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm FPH

1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm PHF

1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm PFH

1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid

Group Type EXPERIMENTAL

Talcid (Hydrotalcite, BAY4516H)

Intervention Type DRUG

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

Famotidine

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Intervention Type DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Interventions

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Talcid (Hydrotalcite, BAY4516H)

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

Intervention Type DRUG

Famotidine

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Intervention Type DRUG

Placebo

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Frankfurt am Main, Hesse, Germany

Site Status

Dresden, Saxony, Germany

Site Status

Leipzig, Saxony, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Ask Central Contact, , Germany

Site Status

Countries

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Germany

Other Identifiers

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11201

Identifier Type: -

Identifier Source: org_study_id