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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Bayer

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

Original Primary Outcome: Time-to-onset of Heartburn Relief [ Time Frame: Up to 24 hours following the first dose of study drug ]

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• Duration of Heartburn Relief [ Time Frame: Up to 4 days of study drug use ]
• Subjective Study Drug Preference [ Time Frame: End of Study, up to 114 days ]
  Subjective study drug preference will be assessed by using data from the questionnaires administered during the study. Participants will answer a series of questions about their heartburn relief and treatment preference.

Information By: Bayer

Dates:
Date Received: April 4, 2012
Date Started: January 2012
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015