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Teprenone in Chronic Non-Atrophic Erosive Gastritis
NCT01284647Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2011
- Primary completion
- Oct 2012
- Countries
- 1
- Sponsor
- Changhai Hospital
- Modality
- Small Molecules
- Drugs
- teprenone
- Conditions
- chronic erosive gastritis
01
Overview
Phase 4, randomised, double-blind trial of teprenone in chronic erosive gastritis (2 arms), sponsored by Changhai Hospital. Primary endpoint: Difference of the modified Lanza score at 4 weeks. Started Feb 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Teprenone
Teprenone 50mg tid + Placebo Sucralfate
Sucralfate
Sucralfate 1g tid + Placebo Teprenone
03
Who it enrols
Adult patients aged 18-65 with endoscopically diagnosed chronic non-atrophic erosive gastritis (Modified Lanza score >= 2) and significant symptoms, excluding those with ulcers, malignancy, severe organ insufficiency, or recent use of affecting medications.
04
Endpoints
Primary
Difference of the modified Lanza score
Secondary
Difference of total effective rate evaluated by histologic examination on inflammation improvement
Difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70
Difference of total effective rate evaluated by clinical symptom score
Difference of total effective rate evaluated by endoscopy
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