Phase 4 N=48 Randomized Treatment

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

Heartburn

Bottom Line

View on ClinicalTrials.gov: NCT01587885 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Time-to-onset of Heartburn Relief — 30.0; 60.0 Minutes — p=<0.0480

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg (Drug); Omeprazole 20 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Time-to-onset of Heartburn Relief	30.0; 60.0	<0.0480 sig
SECONDARY Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time	20.5; 13.6; 52.3; 27.3; 75.0; 61.4	—
SECONDARY Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire	14; 17; 9; 8	—
SECONDARY Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire	16; 16; 7; 1; 8	—
SECONDARY Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire	17; 17; 6; 8	—
SECONDARY Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire	30.0; 30.0; 27.5; 25.0; 22.5; 32.5	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01587885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.