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Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587885
First Posted: April 30, 2012
Last Update Posted: March 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent heartburn.

Condition Intervention Phase
Heartburn Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg Drug: Omeprazole 20 mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol PT 11-29: Randomized, Open-label, Cross-over Pilot Study to Evaluate and Compare Two Omeprazole Containing Products for Relief of Frequent Heartburn

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time-to-onset of Heartburn Relief [ Time Frame: Start of treatment until onset of heartburn relief, up to 24 hours ]

    Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:

    Absent (0): Heartburn is not present.

    Mild (1): Heartburn did not last long or was easily tolerated.

    Moderate (2): Heartburn caused discomfort and interrupted usual activities.

    Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating.



Secondary Outcome Measures:
  • Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time [ Time Frame: Start of treatment until onset of heartburn relief, up to 72 hours ]

    Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:

    Absent (0): Heartburn is not present.

    Mild (1): Heartburn did not last long or was easily tolerated.

    Moderate (2): Heartburn caused discomfort and interrupted usual activities.

    Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating.


  • Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire [ Time Frame: At end of study (approx. Study Day 40) ]
    Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.

  • Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire [ Time Frame: At end of study (approx. Study Day 40) ]
    Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.

  • Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire [ Time Frame: At end of study (approx. Study Day 40) ]
    Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.

  • Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire [ Time Frame: End of treatment period 1 and end of treatment period 2 ]
    End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.


Enrollment: 48
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Capsules, orally
Other Name: Zegerid™
Drug: Omeprazole 20 mg
Tablets, orally
Other Name: Prilosec OTC™
Active Comparator: Omeprazole 20 mg
Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Capsules, orally
Other Name: Zegerid™
Drug: Omeprazole 20 mg
Tablets, orally
Other Name: Prilosec OTC™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females of reproductive potential must demonstrate a negative urine pregnancy test and agree to use an acceptable method of birth control
  • Suffer from frequent heartburn
  • Refrain from taking non-study medicine or treatment for heartburn for the duration of the study
  • Be free of any clinically significant disease that requires a physician's care
  • Read and understand English

Exclusion Criteria:

  • Any significant medical condition which is a contraindication to the use of omeprazole or sodium bicarbonate
  • Known hypersensitivity to the study drugs or any components
  • Experiencing any of the following: trouble or pain with swallowing food, vomiting with blood, bloody or black stools
  • Participation in another investigational study within 4 weeks prior to the screening visit.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01587885     History of Changes
Other Study ID Numbers: 18131
PT 11-29 ( Other Identifier: Study Number )
0764A-036 ( Other Identifier: Merck )
First Submitted: April 4, 2012
First Posted: April 30, 2012
Results First Submitted: April 4, 2013
Results First Posted: May 22, 2013
Last Update Posted: March 11, 2015
Last Verified: February 2015

Keywords provided by Bayer:
Frequent Heartburn
Omeprazole
Omeprazole, sodium bicarbonate drug combination
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Omeprazole
Omeprazole, sodium bicarbonate drug combination
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors