Heartburn
Conditions
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
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.
Interventions
DRUGOmeprazole 20 mg + Sodium Bicarbonate 1100 mg
Capsules, orally
DRUGOmeprazole 20 mg
Tablets, orally
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-onset of Heartburn Relief | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were randomized and received study drug. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 | Failure to Return | 0 | 1 |
| Treatment Period 1 | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 12.57 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 48 |
| serious Total, serious adverse events | 0 / 45 | 0 / 48 |
Outcome results
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.
Time frame: Start of treatment until onset of heartburn relief, up to 24 hours
Population: Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Time-to-onset of Heartburn Relief | 30.0 Minutes |
| Omeprazole 20 mg | Time-to-onset of Heartburn Relief | 60.0 Minutes |
p-value: <0.048Regression, Cox
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.
Time frame: At end of study (approx. Study Day 40)
Population: Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire | Preferred omeprazole+sodium bicarbonate | 14 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire | Preferred omeprazole | 17 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire | Preferred both equally | 9 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire | Missing data | 8 participants |
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.
Time frame: At end of study (approx. Study Day 40)
Population: Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire | Preferred omeprazole+sodium bicarbonate | 16 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire | Preferred omeprazole | 16 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire | Preferred both equally | 7 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire | Preferred neither | 1 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire | Missing data | 8 participants |
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.
Time frame: At end of study (approx. Study Day 40)
Population: Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire | Preferred omeprazole+sodium bicarbonate | 17 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire | Preferred omeprazole | 17 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire | Preferred both equally | 6 participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire | Missing data | 8 participants |
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.
Time frame: End of treatment period 1 and end of treatment period 2
Population: Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symtoms caused trouble falling asleep | 27.5 percentage of partcipants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | slept on incline due to heartburn symptoms | 35.0 percentage of partcipants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symptoms awoke participant | 22.5 percentage of partcipants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | medicine helped with full night's rest | 90.0 percentage of partcipants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symptoms affected daily activities | 30.0 percentage of partcipants |
| Omeprazole 20 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | medicine helped with full night's rest | 95.0 percentage of partcipants |
| Omeprazole 20 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symptoms affected daily activities | 30.0 percentage of partcipants |
| Omeprazole 20 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symtoms caused trouble falling asleep | 25.0 percentage of partcipants |
| Omeprazole 20 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | heartburn symptoms awoke participant | 32.5 percentage of partcipants |
| Omeprazole 20 mg | Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire | slept on incline due to heartburn symptoms | 47.5 percentage of partcipants |
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.
Time frame: Start of treatment until onset of heartburn relief, up to 72 hours
Population: Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤30 minutes | 52.3 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤180 minutes | 100.0 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤90 minutes | 90.9 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤1440 minutes (24 hours) | 100.0 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤60 minutes | 75.0 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤2880 minutes (48 hours) | 100.0 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤120 minutes | 95.5 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤4320 minutes (72 hours) | 100.0 percentage of participants |
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤15 minutes | 20.5 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤4320 minutes (72 hours) | 100.0 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤15 minutes | 13.6 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤30 minutes | 27.3 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤60 minutes | 61.4 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤90 minutes | 75.0 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤120 minutes | 88.6 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤180 minutes | 90.9 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤1440 minutes (24 hours) | 93.2 percentage of participants |
| Omeprazole 20 mg | Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time | ≤2880 minutes (48 hours) | 95.5 percentage of participants |