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

Bayer

Status and phase: Completed; Phase 4

Conditions: Heartburn

Treatments: Drug: Talcid (Hydrotalcite, BAY4516H); Drug: Placebo; Drug: Famotidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928888

11201 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 559 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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559 participants in 6 patient groups

Arm HFP

Experimental group

Description:

1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)

Arm HPF

Experimental group

Description:

1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)

Arm FHP

Experimental group

Description:

1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)

Arm FPH

Experimental group

Description:

1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)

Arm PHF

Experimental group

Description:

1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)

Arm PFH

Experimental group

Description:

1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid

Treatment:

Drug: Placebo

Drug: Famotidine

Drug: Talcid (Hydrotalcite, BAY4516H)