Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | administered 2 tablets of placebo three times daily for two weeks |
|
| DA-9601(StillenĀ®) 180mg | Experimental | administered 1 tablet of placebo and 1 tablet of DA-9601(StillenĀ®) three times daily for two weeks |
|
| DA-9601(StillenĀ®) 360mg | Experimental | administered 2 tablets of DA-9601(StillenĀ®) three times daily for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StillenĀ® Tab | Drug | Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade | evaluated in 5 levels of "Significant improvement ⢠Moderate improvement ⢠Mild improvement ⢠No improvement ⢠Exacerbation" | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with peptic ulcer (excluding scars) and reflux esophagitis
Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial
Patients using protective agent enhancers at the start of the trial ⣠Patients with recurrence observed during maintenance therapy at the start of the trial
Patients with a history of gastrectomy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Medical Center, Division of Gastroenterology | Suwon | Gyeonggi-do | 16499 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| StillenĀ® Tab Placebo | Drug | Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks |
|
| ID | Term |
|---|---|
| C116959 | DA 9601 |
Not provided
Not provided
Not provided