Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

Eisai

Status and phase: Completed; Phase 4

Conditions: Gastric Ulcer; Acute Gastritis

Treatments: Drug: Selbex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190657

P216

Details and patient eligibility

About

This is a self-controlled, open, multiple-center clinical trial.

Enrollment: 1,184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age is over 18 years old , men or women
2. Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
3. Signed the informed consent forms.

Exclusion criteria

1. Patients without inclusion criteria
2. Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
3. Patients with other digestive diseases.
4. Patients with operation on stomach and duodenum.
5. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
6. Patients with severity trauma, surgery, infection and shock.
7. Patients with any kind of tumor
8. Women either pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,184 participants in 2 patient groups

Selbex 50mg (14 days)

Experimental group

Treatment:

Drug: Selbex

Drug: Selbex

Selbex 50mg (56 days)

Experimental group

Treatment:

Drug: Selbex

Drug: Selbex