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Completed

NCT Number: NCT01587885

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

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.

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Drug

Capsules, orally

Other names: Zegerid™

Omeprazole 20 mg

Drug

Tablets, orally

Other names: Prilosec OTC™

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2012
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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