Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03418337
Status:
UNKNOWN
Last Update Posted:
2018-02-01
First Post:
2018-01-18
Brief Title:
Comparison of the Efficiency of Two Different PPI Formula in Atypical GERD
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Comparison of the Efficiency of Two Different PPI Formula in Treatment of Atypical GERD Patients a Randomized Study
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with atypical gastro-esophageal reflux disease GERD include cough globus and non-cardiac chest pain NCCP usually require more aggressive or double dose proton pump inhibitor PPI therapy than patients with typical GERD Dexlansoprazole is a new dual delayed release formulation of PPI that increases the mean intragastric pH during a 24-hour period The prospective open-label randomized study aims to compare the efficacy of two different PPI formula in treating patients with atypical GERD symptoms
Patients with atypical GERD symptoms and a total Reflux Symptom Index RSI score 13 cough globus and NCCP will be invited to participate Personal characteristics including age sex body mass index and the severity of erosive esophagitis will be recorded After enrollment 120 subjects will randomly assign at a 11 ratio to receive either oral lansoprazole Takepron OD 30 mg once daily before breakfast or oral dexilansoprazole Dexilant 60 mg once daily before breakfast for 8 weeks Subjects will record their symptoms cough globus NCCP heart burn and acid regurgitation at daytime and nighttime everyday via diary for 8 weeks The primary endpoint is to compare the cumulated incidence of each symptom free during 8-week therapy period between the two study groups The secondary endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug adverse effects
Data will be analyzed with SPSS Statistical Software for descriptive statistics percentage mean standard error and 95 confidence interval and analytical statistics chi-square test ANOVA and generalized estimation equation GEE
Patients with atypical GERD symptoms and a total Reflux Symptom Index RSI score 13 cough globus and NCCP will be invited to participate Personal characteristics including age sex body mass index and the severity of erosive esophagitis will be recorded After enrollment 120 subjects will randomly assign at a 11 ratio to receive either oral lansoprazole Takepron OD 30 mg once daily before breakfast or oral dexilansoprazole Dexilant 60 mg once daily before breakfast for 8 weeks Subjects will record their symptoms cough globus NCCP heart burn and acid regurgitation at daytime and nighttime everyday via diary for 8 weeks The primary endpoint is to compare the cumulated incidence of each symptom free during 8-week therapy period between the two study groups The secondary endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug adverse effects
Data will be analyzed with SPSS Statistical Software for descriptive statistics percentage mean standard error and 95 confidence interval and analytical statistics chi-square test ANOVA and generalized estimation equation GEE
Detailed Description:
We conduct a prospective randomized study since July 2017 after IRB approval Patients between the ages of 20 and 80 years presenting to the gastroenterology outpatient clinic for atypical GERD symptoms cough globus and NCCP with or without typical symptoms heartburn or acid regurgitation of GERD will be invited to participate After signing informed consents and screening patients with atypical GERD symptoms for more than one month and with a total Reflux Symptom Index RSI score 13 were eligible for enrollmentPatients who currently took pro-kinetic agents baclofen antacid sucralfate histamin-2 receptor antagonists PPI antitussive non-steroid anti-inflammatory drugs anxiolytics or anti-depressants or takes aforementioned medication during study period who have severe cardiac pulmonary hepatic or renal disease who have uncured underlying malignancy will be excluded as are subjects with laryngeal or pharyngeal disorders a history of gastrointestinal GI surgery symptoms of GI tract obstruction or a contraindication for PPI use
Personal characteristics including age sex habit of drinking and smoking body mass index BMI waist circumference and underlying co-morbidity including diabetes hypertension and dyslipidemia will be recorded The findings of esophageal gastroduodenal scopy EGD will be recorded including the severity of erosive esophagitis Los Angeles grade A-D or non-erosive reflux diseaseThe symptoms of atypical GERD including cough globus sensation and NCCP and the symptoms of typical GERD heart burn and acid regurgitation will be recorded everyday daytime and night respectively via diary before PPI therapy for 2 days and after PPI therapy for 8 weeks The definitions of cough globus sensation NCCP heart burn and acid regurgitation will be according to a previous publication After enrollment 120 subjects will randomly assign at a 11 ratio to receive either oral lansoprazole Takepron OD 30 mg Takeda Co Ltd Tokyo Japan once daily before breakfast or oral dexilansoprazole Dexilant 60 mg Takeda Co Ltd Tokyo Japan once daily before breakfast for 8 weeks Subjects will record their symptoms cough globus NCCP heart burn and acid regurgitation at daytime and nighttime everyday for 8 weeks Symptoms suspecting drug adverse effect including nausea diarrhea constipation headache dizziness fatigue flatulence etc will be recorded for 8 weeks Head elevation during sleeping or on diet for body weight reduction medication with pro-kinetic agents baclofen antacid sucralfate histamin-2 receptor antagonists other PPI antitussive non-steroid anti-inflammatory drugs anxiolytics or anti-depressants will not be allowed during study period
Endpoints We will evaluate the response rate symptom free everyday during the 8-week PPI therapy for cough globus sensation NCCP acid regurgitation and heartburn respectively The primary endpoint is to compare the cumulated incidence and the time of each symptom free during 8-week therapy period between the two study groups The secondary endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug adverse effects
Personal characteristics including age sex habit of drinking and smoking body mass index BMI waist circumference and underlying co-morbidity including diabetes hypertension and dyslipidemia will be recorded The findings of esophageal gastroduodenal scopy EGD will be recorded including the severity of erosive esophagitis Los Angeles grade A-D or non-erosive reflux diseaseThe symptoms of atypical GERD including cough globus sensation and NCCP and the symptoms of typical GERD heart burn and acid regurgitation will be recorded everyday daytime and night respectively via diary before PPI therapy for 2 days and after PPI therapy for 8 weeks The definitions of cough globus sensation NCCP heart burn and acid regurgitation will be according to a previous publication After enrollment 120 subjects will randomly assign at a 11 ratio to receive either oral lansoprazole Takepron OD 30 mg Takeda Co Ltd Tokyo Japan once daily before breakfast or oral dexilansoprazole Dexilant 60 mg Takeda Co Ltd Tokyo Japan once daily before breakfast for 8 weeks Subjects will record their symptoms cough globus NCCP heart burn and acid regurgitation at daytime and nighttime everyday for 8 weeks Symptoms suspecting drug adverse effect including nausea diarrhea constipation headache dizziness fatigue flatulence etc will be recorded for 8 weeks Head elevation during sleeping or on diet for body weight reduction medication with pro-kinetic agents baclofen antacid sucralfate histamin-2 receptor antagonists other PPI antitussive non-steroid anti-inflammatory drugs anxiolytics or anti-depressants will not be allowed during study period
Endpoints We will evaluate the response rate symptom free everyday during the 8-week PPI therapy for cough globus sensation NCCP acid regurgitation and heartburn respectively The primary endpoint is to compare the cumulated incidence and the time of each symptom free during 8-week therapy period between the two study groups The secondary endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None