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| ID | Type | Description | Link |
|---|---|---|---|
| ACID CONTROL EXPLORATORY STUDY | Other Identifier | Alias Study Number |
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The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 20 mg once daily | Experimental | Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening |
|
| Esomeprazole 20 mg twice daily | Experimental | Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening |
|
| Placebo | Placebo Comparator | Placebo administered orally in the morning and placebo administered orally in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole 20 mg | Drug | Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn | Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported. | Day 8 up to Day 14 |
| Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4 | Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported. | Baseline, Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73102 | United States | ||
| St. Anthony Hospital - Conference Rooms |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30255418 | Derived | Miner PB, Johnson DA, Katz PO, Li J, Gatoulis SC, Pollack C. Pilot, Randomized, Blinded, Placebo-Controlled Trial Investigating the Correlation Between Acid Control and Heartburn Relief with 14 Days of Esomeprazole Treatment. Adv Ther. 2018 Nov;35(11):2024-2040. doi: 10.1007/s12325-018-0792-z. Epub 2018 Sep 25. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14. |
| FG001 | Esomeprazole 20 mg Once Daily + Placebo | Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14. |
| FG002 | Placebo | Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14. |
| BG001 | Esomeprazole 20 mg Once Daily + Placebo | Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14. |
| 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 | Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn | Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported. | Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14. | Posted | Number | participants | Day 8 up to Day 14 |
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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 | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (v19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| 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 |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| Placebo | Drug | Placebo capsules |
|
| Oklahoma City |
| Oklahoma |
| 73102 |
| United States |
| To obtain contact information for a study center near you, click here. | View source |
| BG002 | Placebo | Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14. |
| OG001 | Esomeprazole 20 mg Once Daily + Placebo | Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14. |
| OG002 | Placebo | Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14. |
|
|
| Primary | Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4 | Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported. | Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14. | Posted | Mean | Standard Deviation | percentage of time | Baseline, Day 14 |
|
|
|
|
| 0 |
| 21 |
| 3 |
| 21 |
| EG001 | Esomeprazole 20 mg Once Daily + Placebo | Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14. | 0 | 22 | 1 | 22 |
| EG002 | Placebo | Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14. | 0 | 12 | 2 | 12 |
| Gastroenteritis viral | Infections and infestations | MedDRA (v19.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (v19.0) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (v19.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (v19.0) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|