Back to results

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

Primary Purpose

Heartburn

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Talcid (Hydrotalcite, BAY4516H)

Famotidine

Placebo

About this trial

This is an interventional treatment trial for Heartburn focused on measuring Acute heartburn episodes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm HFP

Arm HPF

Arm FHP

Arm FPH

Arm PHF

Arm PFH

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01928888

First Posted

August 20, 2013

Last Updated

December 23, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01928888

Brief Title

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

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heartburn

Keywords

Acute heartburn episodes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

559 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm HFP

Arm Type

Experimental

Arm Description

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

Arm Title

Arm HPF

Arm Type

Experimental

Arm Description

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

Arm Title

Arm FHP

Arm Type

Experimental

Arm Description

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

Arm Title

Arm FPH

Arm Type

Experimental

Arm Description

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

Arm Title

Arm PHF

Arm Type

Experimental

Arm Description

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

Arm Title

Arm PFH

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Talcid (Hydrotalcite, BAY4516H)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Famotidine

Intervention Description

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Primary Outcome Measure Information:

Title

Total heartburn relief over 0-60 min

Description

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

Secondary Outcome Measure Information:

Title

Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine

Description

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

Title

Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04107

Country

Germany

City

ask Central Contact

Country

Germany

City

Berlin

ZIP/Postal Code

10437

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs