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

Heartburn Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928888
• Other study ID #: 11201
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2013
• Last updated: December 23, 2014
• Start date: May 2003
• Est. completion date: February 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
• Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
• Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 60 minutes	No
Secondary	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.	up to 30 min	No
Secondary	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.	up to 3 h	No

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