Clinical 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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,

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.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: 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.


Original Primary Outcome: Total heartburn relief over 0-60 min [ Time Frame: up to 60 minutes ]

The total heartburn relief is calculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.


Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome:

  • 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 calculated 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 [ Time Frame: up to 3 h ]
    The total heartburn relief is calculated as sum of the heartburn relief scores based on a 5-point verbal rating scale.


Information By: Bayer

Dates:
Date Received: August 20, 2013
Date Started: May 2003
Date Completion:
Last Updated: December 23, 2014
Last Verified: December 2014