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

December 23, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
559

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10437
      • ask Central Contact, Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm HFP
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
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
Experimental: Arm HPF
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
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
Experimental: Arm FHP
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
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
Experimental: Arm FPH
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
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
Experimental: Arm PHF
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
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
Experimental: Arm PFH
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total heartburn relief over 0-60 min
Time Frame: up to 60 minutes
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
up to 60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine
Time Frame: up to 30 min
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
up to 30 min
Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine
Time Frame: up to 3 h
The total heartburn relief is claculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.
up to 3 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11201 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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