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NCT Number: NCT01928888

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

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.

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Frankfurt am Main, Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talcid (Hydrotalcite, BAY4516H)

Drug

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

Famotidine

Drug

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Placebo

Drug

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Aug 27, 2013
Registry last updated
Dec 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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