An interventional study of dexilansoprazole (Dexilant 60 mg) and lansoprazole (Takepron OD 30 mg) in Compare the Response Rate of Atypical GERD After PPI Therapy, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
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 1:1 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).
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 enrollment.Patients 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 disease).The 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 1:1 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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 338 studies on the registry; 74 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After randomization, 60 subjects will receive oral dexlansoprazole (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.
Drug: dexilansoprazole (Dexilant 60 mg)
After randomization, 60 subjects will receive oral lansoprazole (Takepron OD 30 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.
Drug: lansoprazole (Takepron OD 30 mg)
evaluate the response rate (symptom free) during the 8-week PPI therapy for atypical GERD between dexlansoprazole group and lansoprazole group
lansoprazole group
The response rate of atypical GERD symptom
evaluate the response rate (symptom free) everyday during the 8-week PPI therapy for cough, globus sensation, NCCP, acid regurgitation, and heartburn respectively
Time frame: 8 weeks
the withdrawal or drop-out rate between the two study groups
the withdrawal or drop-out rate due to poor symptoms response or drug adverse effects
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexlansoprazole
Taipei Veterans General Hospital, Taiwan →