Korean J Gastrointest Endosc.
2011 Apr;42(4):215-221.
Efficacy and Safety of Albis(R) in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study
- Affiliations
-
- 1Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea. choim@catholic.ac.kr
- 2Department of Internal Medicine, Pusan Paik Hospital, Inje University College of Medicine, Busan, Korea.
- 3Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
- 6Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea.
- 7Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Abstract
- BACKGROUND/AIMS
Albis(R) is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to demonstrate the efficacy and safety superiority of Albis(R) compared to Stillen(R) for treating erosive gastritis.
METHODS
This study was a randomized, double-blind, multi-center trial. The primary endpoint was 2 weeks of treatment.
RESULTS
Of the 229 patients in the intention-to-treat (ITT) population, 87 from the Albis(R), and 96 from the Stillen(R) group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis(R)(R) group and the control in both the PP (42.5%, 39.6%) and ITT (35.3%, 34.5%) populations. The endoscopic cure of erosion was also not different in the Albis(R) group than that in the control group in both the PP (32.3%, 31.3%) and ITT (27.6%, 27.4%) populations. The endoscopic improvement rate for hemorrhage, edema, and erythema were also not different between the two groups in both the PP and ITT populations. No statistically significant differences were observed for adverse events between the two groups.
CONCLUSIONS
Half of the approved dose of Albis(R) for peptic ulcers was superior to Stillen(R). A low dosage of Albis(R) is more cost efficient and safe than that of Stillen(R).
Keyword
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Efficacy of Albis for the Prevention of Gastric Mucosal Injury Concomitant with the Use of Low-Dose Aspirin: A Prospective, Randomized, Placebo-Controlled Study
- Adjuvant Sertraline Treallnent for Chronic Schizophrenia :A Randomized, Double Blind, Placeho-Controlled Study
- Effects of cetirizine in dogs with chronic atopic dermatitis: a randomized, double blind, placebo-controlled trial
- Double-blind, Parallel-group, Placebo-controlled Multi-center Clinical Trial for Evaluating the Efficacy and Safety of Phentermine Hydrochloride in Obese Patients
- Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study
