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Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied by acid regurgitation and other symptoms, has a substantial negative impact on a patients' quality of life. Although a number of treatment options are available, a more effective therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD using an immediate-release omeprazole/sodium bicarbonate formulation when compared with delayed-release omeprazole (Losec®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid | Experimental | Treatment of heartburn with Zegerid |
|
| Losec | Active Comparator | Treatment of heartburn with Losec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zegerid | Drug | 20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient | Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more | up to 14 days following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Sustained Partial Response | Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more | up to 14 days |
| Median Time to Sustained Total Relief |
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Inclusion Criteria:
Study patients will be included in the study if they satisfy the following criteria:
Inclusion criteria applicable to Screening period:
Exclusion Criteria:
Study patients will be excluded if they meet any of the following criteria:
Exclusion criteria applicable to Screening period:
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| Name | Affiliation | Role |
|---|---|---|
| J Regula, MD | Dept of Gastroenterology and Hepatology, Roentgena, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology, Oncology Centre, Roentgena | Warsaw | 02-781 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25706883 | Derived | Walker D, Ng Kwet Shing R, Jones D, Gruss HJ, Regula J. Challenges of correlating pH change with relief of clinical symptoms in gastro esophageal reflux disease: a phase III, randomized study of Zegerid versus Losec. PLoS One. 2015 Feb 23;10(2):e0116308. doi: 10.1371/journal.pone.0116308. eCollection 2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid | Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day |
| FG001 | Losec | Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zegerid | Treatment of heartburn with Zegerid |
| BG001 | Losec | Treatment of heartburn with Losec |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient | Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more | mITT | Posted | Median | 95% Confidence Interval | Minutes | up to 14 days following treatment |
|
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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 | Zegerid | Treatment of heartburn with Zegerid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Ng Kwet Shing | Norgine Ltd | +441895453584 | RNg@Norgine.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Losec | Drug | 20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days. |
|
Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more
| 14 days |
| Percentage of Patients Responding in 45 Minutes | percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes | up to 14 days |
| Percentage of Patients Responding in 60 Minutes | Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes | 14 days |
| Percentage of Patients Responding in 90 Minutes | Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes | 14 days |
| Physician Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Median Time to Sustained Partial Response | Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more | mITT | Posted | Median | 95% Confidence Interval | Minutes | up to 14 days |
|
|
|
|
| Secondary | Median Time to Sustained Total Relief | Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more | mITT | Posted | Median | 95% Confidence Interval | Minutes | 14 days |
|
|
|
|
| Secondary | Percentage of Patients Responding in 45 Minutes | percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes | mITT | Posted | Number | 95% Confidence Interval | percentage of patients | up to 14 days |
|
|
|
|
| Secondary | Percentage of Patients Responding in 60 Minutes | Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes | mITT | Posted | Number | 95% Confidence Interval | Percentage of patients | 14 days |
|
|
|
|
| Secondary | Percentage of Patients Responding in 90 Minutes | Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes | mITT | Posted | Number | 95% Confidence Interval | Percentage of patients | 14 days |
|
|
|
|
| 0 |
| 122 |
| 4 |
| 122 |
| EG001 | Losec | Treatment of heartburn with Losec | 0 | 117 | 4 | 117 |
| abdominal pain upper | Gastrointestinal disorders |
|
| flatulence | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Influenza like illness | General disorders |
|
| paronychia | Infections and infestations |
|
| headache | Nervous system disorders |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders |
|
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| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 0.755 |
| Mean Difference (Final Values) |
| -2.2 |
| 2-Sided |
| 95 |
| -15.0 |
| 10.6 |
| No |
| Superiority or Other |
| Sustained total relief | Regression, Cox | 0.194 | Mean Difference (Final Values) | 6.8 | 2-Sided | 95 | -3.6 | 17.2 | No | Superiority or Other |
| 0.518 |
| Mean Difference (Final Values) |
| -4.7 |
| 2-Sided |
| 95 |
| -17.6 |
| 8.2 |
| No |
| Superiority or Other |
| Sustained total relief | Regression, Cox | 0.794 | Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | -11.2 | 13.1 | No | Superiority or Other |
| 0.751 |
| Mean Difference (Final Values) |
| -2.8 |
| 2-Sided |
| 95 |
| -14.7 |
| 9.1 |
| No |
| Superiority or Other |
| Sustained total relief | Regression, Cox | 0.690 | Mean Difference (Final Values) | -3.4 | 2-Sided | 95 | -16.4 | 9.6 | No | Superiority or Other |