A Phase 3 interventional study of AGSPT201 Tab contains S-pantoprazole in Gastroesophageal Reflux Disease, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Completed at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-09-21.
Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18\~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 154 is above the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 4 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:
Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)
Drug: AGSPT201 Tab contains S-pantoprazole
comparison of Pantoloc Tab 40mg
Also known as: AGSPT201 Tab. (Brand name Deflux tab)
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions.
Time frame: 4 week
Absence and/or improvement of typical reflux symptoms
Patients recorded the improvement of typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation on diary card. The presence of symptoms are classified to absence (Score 0), mild (Score 1), moderate (Score 2), severe (Score 3) and very severe (Score 4).
Time frame: 4 week
This study is completed, as verified in Sep 2011. 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.
Ahn-Gook Pharmaceuticals Co.,Ltd →