Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02759393
Status:
UNKNOWN
Last Update Posted:
2016-05-03
First Post:
2016-04-29
Brief Title:
Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Comparing Dexlansoprazole With Double-dose Lansoprazole to Achieve Sustained Symptomatic Response in Overweight and Obesity Patients With Reflux Esophagitis in Los Angeles Grades A B
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
ENROLLING_BY_INVITATION
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:
The purpose of this study is to investigate whether dexlansoprazole can be as effective as double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles grades A B
Detailed Description:
This study is conducted in National Cheng Kung University Hospital a tertiary health care center in Tainan Taiwan All participants give written informed consent before enrollment After panendoscopy to confirm enrollment eligibility and reflux esophagitis in Los Angeles A or B all patients are evenly randomized into a DEX group receiving 8-week dexlansoprazole 60 mg per day or double-dose PPI group receiving 8-week lansoprazole 30 mg twice daily The enrolled patients are randomized by two series of sealed envelopes containing a prescheduled group code one series for the overweight patients and the other for the obese patients In each series of the sealed envelopes the number of the group code will be equal within every 10 sealed envelopes
In each patient the demographic factors and the genotype of S-mephenytoin 4-hydroxylase CYP2C19 will be checked and defined as poor metabolizer PM homologous HomoEM or heterologous extensive metabolizer HeteroEM Each patient is treated continuously with dexlansoprazole 60 mg per day or lansoprazole 30 mg twice daily for eight weeks During this 8-week study period each patient is requested to record their daily clinical symptoms of reflux esophagitis on a special sheet including the severity of acid regurgitation AR score 0 free from symptoms score 1 attack episodes 5 times per day score 2 6-10 times per day score 3 more than 10 episodes per day heartburn HB score 0 absence of symptoms score 1 tolerable events not interfering with daily work score 2 intolerable events interfering with daily work but not needing medication to relieve the symptoms score 3 complaints interfering with the completion of daily work or causing the patient to wake up during the night with cough or combined with any other non-specific complaints The patients are scheduled to return to clinics for drug refills and to hand back daily symptom records at the end of the fourth and eighth week of treatment
The cumulative proportions of patients with sustained symptomatic response SSR defined as free from acid regurgitation and heartburn for the last seven days are recorded during the 8-week study period for each study group All of the patients starting the treatment are included for the intention-to-treat ITT analysis of the rate of SSR If patients have obvious symptoms despite continuous PPI usage and have an unscheduled visit to load up on additional PPIs during the study the case is then dropped from the per-protocol PP analysis In addition patients lost to follow-up are excluded from the PP analysis to determine the rate of SSR Besides comparing the difference of the rate of SSR between the two study groups the study also determined whether patients with different CYP2C19 genotypes have differences in the cumulative rates of SSR after therapy between the two study groups
In each patient the demographic factors and the genotype of S-mephenytoin 4-hydroxylase CYP2C19 will be checked and defined as poor metabolizer PM homologous HomoEM or heterologous extensive metabolizer HeteroEM Each patient is treated continuously with dexlansoprazole 60 mg per day or lansoprazole 30 mg twice daily for eight weeks During this 8-week study period each patient is requested to record their daily clinical symptoms of reflux esophagitis on a special sheet including the severity of acid regurgitation AR score 0 free from symptoms score 1 attack episodes 5 times per day score 2 6-10 times per day score 3 more than 10 episodes per day heartburn HB score 0 absence of symptoms score 1 tolerable events not interfering with daily work score 2 intolerable events interfering with daily work but not needing medication to relieve the symptoms score 3 complaints interfering with the completion of daily work or causing the patient to wake up during the night with cough or combined with any other non-specific complaints The patients are scheduled to return to clinics for drug refills and to hand back daily symptom records at the end of the fourth and eighth week of treatment
The cumulative proportions of patients with sustained symptomatic response SSR defined as free from acid regurgitation and heartburn for the last seven days are recorded during the 8-week study period for each study group All of the patients starting the treatment are included for the intention-to-treat ITT analysis of the rate of SSR If patients have obvious symptoms despite continuous PPI usage and have an unscheduled visit to load up on additional PPIs during the study the case is then dropped from the per-protocol PP analysis In addition patients lost to follow-up are excluded from the PP analysis to determine the rate of SSR Besides comparing the difference of the rate of SSR between the two study groups the study also determined whether patients with different CYP2C19 genotypes have differences in the cumulative rates of SSR after therapy between the two study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None