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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01587885
First received: April 4, 2012
Last updated: August 29, 2014
Last verified: August 2014
  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: 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 Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time-to-onset of Heartburn Relief [ Time Frame: Start of treatment until onset of heartburn relief, up to 24 hours ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01587885     History of Changes
Other Study ID Numbers: 0764A-036, PT 11-29
Study First Received: April 4, 2012
Results First Received: April 4, 2013
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
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
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Omeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014