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| ID | Type | Description | Link |
|---|---|---|---|
| PT 11-29 | Other Identifier | Study Number | |
| 0764A-036 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Drug | Capsules, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg | 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. |
| FG001 | Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were randomized and received study drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | Minutes | Start of treatment until onset of heartburn relief, up to 24 hours |
|
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Three participants discontinued the study prior to receiving Omeprazole 20 mg + Sodium Bicarbonate 1100 mg. Therefore, only 45 participants received Omeprazole 20 mg + Sodium Bicarbonate 1100 mg.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D017693 | Sodium Bicarbonate |
| C494109 | omeprazole, sodium bicarbonate drug combination |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole 20 mg | Drug | Tablets, orally |
|
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| Start of treatment until onset of heartburn relief, up to 72 hours |
| 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) |
| 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) |
| 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) |
| 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 |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG000 | Omeprazole 20 mg + Sodium Bicarbonate 1100 mg | Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days. |
| OG001 | Omeprazole 20 mg | Participants will receive omeprazole 20 mg once a day for 4 days. |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Start of treatment until onset of heartburn relief, up to 72 hours |
|
|
|
| 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. | 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. | Posted | Number | participants | At end of study (approx. Study Day 40) |
|
|
|
| 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. | 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. | Posted | Number | participants | At end of study (approx. Study Day 40) |
|
|
|
| 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. | 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. | Posted | Number | participants | At end of study (approx. Study Day 40) |
|
|
|
| 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. | 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. | Posted | Number | percentage of partcipants | End of treatment period 1 and end of treatment period 2 |
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| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Omeprazole 20 mg | 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. | 0 | 48 | 0 | 48 |
MERCK retains the title to and exclusive right to publish all documentation, research data, records, raw data, other work product, data, and/or results generated with respect to the Services and/or the Study ("Work Product"). Such Work Product will be retained in the CRO archive in compliance with regulatory requirements.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| ≤60 minutes |
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| ≤90 minutes |
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| ≤120 minutes |
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| ≤180 minutes |
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| ≤1440 minutes (24 hours) |
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| ≤2880 minutes (48 hours) |
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| ≤4320 minutes (72 hours) |
|
| Title | Measurements |
|---|---|
|
| Missing data |
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| Title | Measurements |
|---|
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| Preferred neither |
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| Missing data |
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| Title | Measurements |
|---|
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| Missing data |
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| heartburn symptoms awoke participant |
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| slept on incline due to heartburn symptoms |
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| medicine helped with full night's rest |
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