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

A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01190657

Enrollment

1184

Registered

2010-08-27

Start date

2010-05-31

Completion date

2013-02-28

Last updated

2013-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastritis, Gastric Ulcer

Keywords

Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis

Brief summary

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

Interventions

DRUGSelbex

50mg/day, 3 times/day, for 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Endoscopic results of ulcer lesion	56 days	Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
Total effective rate	56 days.	Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.

Secondary

Measure	Time frame
Symptoms improved level	56 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026