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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

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ClinicalTrials.gov Identifier: NCT01928888
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heartburn Drug: Talcid (Hydrotalcite, BAY4516H) Drug: Famotidine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 559 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, and a Single Dose of Placebo in Patients With Acute Heartburn Episodes.
Study Start Date : May 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arm Intervention/treatment
Experimental: Arm HFP
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Experimental: Arm HPF
1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Experimental: Arm FHP
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Experimental: Arm FPH
1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Experimental: Arm PHF
1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine

Experimental: Arm PFH
1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
Drug: Talcid (Hydrotalcite, BAY4516H)
2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine

Drug: Famotidine
2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg

Drug: Placebo
2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928888


Locations
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Germany
Frankfurt, Hessen, Germany, 60596
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04107
ask Central Contact, Germany
Berlin, Germany, 10437
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01928888     History of Changes
Other Study ID Numbers: 11201
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Acute heartburn episodes

Additional relevant MeSH terms:
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Famotidine
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Hydrotalcite
Aluminum Hydroxide
Magnesium Hydroxide
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antacids
Adjuvants, Immunologic
Immunologic Factors