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

NCT01587885 | Completed Phase 4 Results

• 3 other identifiers: 18131PT 11-290764A-036
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heartburn

Keywords

Frequent Heartburn; Omeprazole; Omeprazole, sodium bicarbonate drug combination; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Proton Pump Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time

  Start of treatment until onset of heartburn relief, up to 72 hours

• Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire

  At end of study (approx. Study Day 40)

• Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire

  At end of study (approx. Study Day 40)

• Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire

  At end of study (approx. Study Day 40)

• Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire

  End of treatment period 1 and end of treatment period 2

Study Arms (2)

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

EXPERIMENTAL

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; Drug: Omeprazole 20 mg

Omeprazole 20 mg

ACTIVE COMPARATOR

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; Drug: Omeprazole 20 mg

Interventions

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg DRUG

Capsules, orally

Also known as: Zegerid™

Omeprazole 20 mg; Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Omeprazole 20 mg DRUG

Tablets, orally

Also known as: Prilosec OTC™

Omeprazole 20 mg; Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Heartburn

Interventions

Omeprazole; Sodium Bicarbonate; omeprazole, sodium bicarbonate drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 30, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 11, 2015
• Results First Posted: May 22, 2013

Record last verified: 2015-02