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Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Disease | Drug: Rabeprazole 20mg bid Drug: Rabeprazole 20mg qd | Phase 3 |
Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus. This disease can be classified in to two subtypes according to the symptoms; Typical symptoms such as heartburn and regurgitation, and atypical symptoms (extra-esophageal symptoms) such as chronic cough, asthma, non-cardiac chest pain, globus sensation, etc.
Acid suppression with proton pump inhibitors is the mainstream of therapy for the extra-esophageal manifestation as well as the typical symptoms of gastroesophageal reflux disease.
However, there is controversy about the efficacy of proton pump inhibitors on extra-esophageal reflux.
Therefore, we aimed to assess the effect of proton pump inhibotor (rabeprazole) on the extra-esophageal manifestation of gastroesophageal reflux disease, through comparison of treatment response with high-dose and standard-dose rabeprazole.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 73 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial. |
| Actual Study Start Date : | October 10, 2012 |
| Actual Primary Completion Date : | May 21, 2014 |
| Actual Study Completion Date : | May 21, 2014 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: High-dose rabeprazole
Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
|
Drug: Rabeprazole 20mg bid
Rabeprazole 20mg tablet b.i.d.
Other Name: Rabiet
|
|
Active Comparator: Standard-dose rabeprazole
Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks
|
Drug: Rabeprazole 20mg qd
Rabeprazole 20mg tablet q.d.
Other Name: Rabiet
|
- Effective improvement of symptoms [ Time Frame: 8 weeks ]
A percentage of subjects showed effective improvement of extra-esophageal symptoms of gastroesophageal reflux disease by assessing the average sum of the questionnaire symptom scores.
The definition of "effective improvement" is the subjects showed ≥50% reduction from the initial questionnaire score.
The symptom questionnaire consists of a 5-graded Likert scale for each symptom to assess intensity of symptoms.
[score 0: no symptoms, score 1: mild symptoms that is not easily felt, score 2: moderate symptoms but not affect daily life, score 3: severe symptoms that hinder daily life or sleep, score 4: very severe symptoms that cannot lead to normal daily life or sleep]
In this trial, extra-esophageal symptoms consist of eight symptoms; non-cardiac chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching and dysphagia.
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age is over 20 years old, under 80 years old, men or women
- Patients who had experienced extra-esophageal symptoms of gastroesophageal reflux disease more than once a week within the last month prior to the start of the study
Exclusion Criteria:
- Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
- Patients administered with anti-thrombotic drugs
- Patients taking other investigational drugs or participating in other clinical studies in 4 weeks
- Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
- Patients with Zollinger-Ellison syndrome
- Patients with any kind of malignant tumor
- Patients with surgery related to gastroesophageal
- Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- Women either pregnant or breast feeding
| Korea, Republic of | |
| Seoul National University Bungdang Hospital | |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620 | |
| Principal Investigator: | Dong Ho Lee, MD, PhD | Seoul National University Bundang Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||
| First Posted Date ICMJE | June 28, 2019 | ||||
| Last Update Posted Date | June 28, 2019 | ||||
| Actual Study Start Date ICMJE | October 10, 2012 | ||||
| Actual Primary Completion Date | May 21, 2014 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Effective improvement of symptoms [ Time Frame: 8 weeks ] A percentage of subjects showed effective improvement of extra-esophageal symptoms of gastroesophageal reflux disease by assessing the average sum of the questionnaire symptom scores.
The definition of "effective improvement" is the subjects showed ≥50% reduction from the initial questionnaire score.
The symptom questionnaire consists of a 5-graded Likert scale for each symptom to assess intensity of symptoms.
[score 0: no symptoms, score 1: mild symptoms that is not easily felt, score 2: moderate symptoms but not affect daily life, score 3: severe symptoms that hinder daily life or sleep, score 4: very severe symptoms that cannot lead to normal daily life or sleep]
In this trial, extra-esophageal symptoms consist of eight symptoms; non-cardiac chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching and dysphagia.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux. | ||||
| Official Title ICMJE | Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial. | ||||
| Brief Summary | This is a single-center, randomized, open-label clinical study to assess the treatment response of high-dose rabeprazole compared with standard-dose rabeprazole in patients with extra-esophageal manifestations of gastroesophageal reflux disease. | ||||
| Detailed Description |
Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus. This disease can be classified in to two subtypes according to the symptoms; Typical symptoms such as heartburn and regurgitation, and atypical symptoms (extra-esophageal symptoms) such as chronic cough, asthma, non-cardiac chest pain, globus sensation, etc. Acid suppression with proton pump inhibitors is the mainstream of therapy for the extra-esophageal manifestation as well as the typical symptoms of gastroesophageal reflux disease. However, there is controversy about the efficacy of proton pump inhibitors on extra-esophageal reflux. Therefore, we aimed to assess the effect of proton pump inhibotor (rabeprazole) on the extra-esophageal manifestation of gastroesophageal reflux disease, through comparison of treatment response with high-dose and standard-dose rabeprazole. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Esophageal Disease | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Cho JH, Shin CM, Yoon H, Park YS, Kim N, Lee DH. Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial. BMC Gastroenterol. 2020 Aug 18;20(1):275. doi: 10.1186/s12876-020-01410-z. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
73 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 21, 2014 | ||||
| Actual Primary Completion Date | May 21, 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04001400 | ||||
| Other Study ID Numbers ICMJE | SNUBH-DHLIDRA | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Dong Ho Lee, Seoul National University Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | IlDong Pharmaceutical Co Ltd | ||||
| Investigators ICMJE |
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| PRS Account | Seoul National University Hospital | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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