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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

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 27, 2013
Last Update Posted Date December 25, 2014
Study Start Date  ICMJE May 2003
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
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 Measures  ICMJE
 (submitted: August 22, 2013)
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.
Change History Complete list of historical versions of study NCT01928888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
  • 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 Measures  ICMJE
 (submitted: August 22, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heartburn
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm HFP
    1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Famotidine, 3rd heartburn episode Placebo
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
  • Experimental: Arm HPF
    1st heartburn episode Intervention Hydrotalcid, 2nd heartburn episode Placebo, 3rd heartburn episode Famotidine
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
  • Experimental: Arm FHP
    1st heartburn episode Intervention Famotidine, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Placebo
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
  • Experimental: Arm FPH
    1st heartburn episode Intervention Famotidine, 2nd heartburn episode Placebo, 3rd heartburn episode Hydrotalcid
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
  • Experimental: Arm PHF
    1st heartburn episode Intervention Placebo, 2nd heartburn episode Hydrotalcid, 3rd heartburn episode Famotidine
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
  • Experimental: Arm PFH
    1st heartburn episode Intervention Placebo, 2nd heartburn episode Famotidine, 3rd heartburn episode Hydrotalcid
    Interventions:
    • Drug: Talcid (Hydrotalcite, BAY4516H)
    • Drug: Famotidine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2014)
559
Original Actual Enrollment  ICMJE
 (submitted: August 22, 2013)
477
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01928888
Other Study ID Numbers  ICMJE 11201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP