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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

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Talcid (Hydrotalcite, BAY4516H)
Famotidine
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

Experimental

Experimental

Experimental

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

First Posted
August 20, 2013
Last Updated
December 23, 2014
Sponsor
Bayer
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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
No

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
No
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

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

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