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

NCT01928888 | Completed Phase 4

• 1 other identifier: 11201
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 5

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.

Conditions

Heartburn

Keywords

Acute heartburn episodes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Total heartburn relief 0-30 min after comparison hydrotalcite vs. placebo and vs famotidine

  up to 30 min

• Total heartburn relief 0-3 h after comparison hydrotalcite vs. placebo and vs famotidine

  up to 3 h

Study Arms (6)

Arm HFP

EXPERIMENTAL

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

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

Arm HPF

EXPERIMENTAL

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

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

Arm FHP

EXPERIMENTAL

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

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

Arm FPH

EXPERIMENTAL

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

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

Arm PHF

EXPERIMENTAL

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

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

Arm PFH

EXPERIMENTAL

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

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

Interventions

Talcid (Hydrotalcite, BAY4516H) DRUG

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

Arm FHP; Arm FPH; Arm HFP; Arm HPF; Arm PFH; Arm PHF

Famotidine DRUG

2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Arm FHP; Arm FPH; Arm HFP; Arm HPF; Arm PFH; Arm PHF

Placebo DRUG

2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Arm FHP; Arm FPH; Arm HFP; Arm HPF; Arm PFH; Arm PHF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Unknown Facility

Frankfurt am Main, Hesse, 60596, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Leipzig, Saxony, 04107, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10437, Germany

Location

Unknown Facility

Ask Central Contact, Germany

Location

MeSH Terms

Conditions

Heartburn

Interventions

hydrotalcite; Famotidine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 27, 2013
• Study Start: May 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: December 25, 2014

Record last verified: 2014-12

Locations

DE (5)