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
Phase 4
Completed
- Conditions
- Heartburn
- Interventions
- Registration Number
- NCT01928888
- Lead Sponsor
- Bayer
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 559
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm HPF Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine Arm HPF Placebo 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine Arm HFP Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo Arm PHF Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine Arm PHF Famotidine 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine Arm HFP Placebo 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo Arm FHP Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo Arm FPH Placebo 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid Arm FPH Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid Arm PFH Talcid (Hydrotalcite, BAY4516H) 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid Arm PFH Placebo 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid Arm FHP Placebo 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo Arm PHF Placebo 1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine Arm HFP Famotidine 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo Arm HPF Famotidine 1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine Arm FHP Famotidine 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo Arm FPH Famotidine 1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid Arm PFH Famotidine 1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
- Primary Outcome Measures
Name Time Method Total heartburn relief over 0-60 min 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 Outcome Measures
Name Time Method Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine 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 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.