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

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587885
• Other study ID #: 18131
• Secondary ID: PT 11-290764A-03
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2012
• Last updated: February 20, 2015
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Capsules, orally
• Omeprazole 20 mg
Tablets, orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-onset of Heartburn Relief	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.	Start of treatment until onset of heartburn relief, up to 24 hours	No
Secondary	Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time	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.	Start of treatment until onset of heartburn relief, up to 72 hours	No
Secondary	Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.	At end of study (approx. Study Day 40)	No
Secondary	Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.	At end of study (approx. Study Day 40)	No
Secondary	Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.	At end of study (approx. Study Day 40)	No
Secondary	Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire	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.	End of treatment period 1 and end of treatment period 2	No