DA-9601 for erosive gastritis: results of a double-blind placebo-controlled phase III clinical trial.
OBJECTIVE
To determine the efficacy and safety of DA-9601 on erosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy.


METHODS
Five hundred and twelve patients with erosive gastritis were divided into three groups. The groups received 180 mg or 360 mg of DA-9601, or 600 mg of cetraxate (Neuer) t.i.d. for 2 wk, respectively. Endoscopic observations were performed before and 2 wk after the treatment, and the cure and improvement rates were investigated.


RESULTS
Of the 512 intention-to-treat (ITT) population, 457 patients comprised the per protocol (PP) analysis. Endoscopic cure rate was significantly higher in the DA-9601 group than in the cetraxate group in both the PP (56%, 58% vs 36%; DA-9601 180 mg, 360 mg and cetraxate, respectively) and ITT (52%, 51% vs 35%) populations. Two DA-9601 groups (180 and 360 mg) had significantly higher endoscopic improvement rates than the cetraxate group in both the PP (67%, 65% vs 46%) and ITT (63%, 58% vs 45%) populations. The percentage of symptom relief over the 2 wk was found not significantly different between groups. During the study, both DA-9601 and cetraxate produced no treatment-associated adverse events.


CONCLUSIONS
From these results, it appears that DA-9601 has excellent efficacy on erosive gastritis. This study also confirms the safety profile of DA-9601.
Dong-A Pharmaceutical Research Institute, 47-5, Sanggal-ri, Kiheung-up, Yongin-shi, Kyunggi-do 449-905, Korea.
Sang-Yong
SY
Seol
Myung-Hwan
MH
Kim
Jong-Sun
JS
Ryu
Myung-Gyu
MG
Choi
Dong-Wook
DW
Shin
Byoung-Ok
BO
Ahn
D000328:Adult; D019306:Artemisia; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005756:Gastritis / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D014148:Tranexamic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
C116959:DA 9601; D005343:Fibrinolytic Agents; D010936:Plant Extracts; C000665:cetraxate; D014148:Tranexamic Acid