Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral placebo tablet |
|
| Rabeprazole sodium 10 mg | Experimental | oral rabeprazole 10 mg enteric-coated tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole sodium | Drug | Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. | Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity. | first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population | comparison between placebo and treatment will be analyzed using two-sample t-test. | 14-day treatment period. |
| Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yufang Lu, MD, PhD | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeffrey L. Newman | Vista | California | 92084 | United States |
The screening phase (1 to 2 weeks) included a 1-week single-blind placebo run-in phase in order to determine baseline heartburn frequency and diary compliance. At the end of the run-in phase, subjects continued the study and entered the randomized treatment phase if they meet the study criteria.
This study was recruited at 39 centers in the US during the period of 10-Oct-2005 and 16-Mar-2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | Rabeprazole 10 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | oral placebo tablet |
| BG001 | Rabeprazole 10 mg | oral enteric-coated tablet |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population | comparison between placebo and treatment will be analyzed using two-sample t-test. | Not Posted | Mean | Standard Deviation | Percentage of participants | 14-day treatment period. | |||||||||
| Secondary | Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population | comparison between placebo and treatment will be analyzed using two-sample t-test. | Not Posted | Mean | Standard Deviation | Percentage of participants |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yufang Lu, MD, PhD, Study Director | Eisai Medical Research Inc. | 201-403-2500 |
Not provided
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Other | Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. |
|
comparison between placebo and treatment will be analyzed using two-sample t-test. |
| 14-day treatment period. |
| Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. | comparison between placebo and treatment will be analyzed using two-sample t-test. | 14-day treatment period. |
| Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. | comparison between placebo and treatment will be analyzed using two-sample t-test. | 14-day treatment period. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| non-compliance with study drug |
|
| other |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 14-day treatment period. |
| Secondary | Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. | comparison between placebo and treatment will be analyzed using two-sample t-test. | Not Posted | Mean | Standard Deviation | 14-day treatment period. |
| Secondary | Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. | comparison between placebo and treatment will be analyzed using two-sample t-test. | Not Posted | Mean | Standard Deviation | 14-day treatment period. |
| Primary | Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. | Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity. | The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment. | Posted | Number | participants | first 24 hours |
|
|
|
|
| 2 |
| 310 |
| 4 |
| 310 |
| EG001 | Rabeprazole 10 mg | 1 | 319 | 7 | 319 |
| abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |