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Rebamipide/Nizatidine Combination vs Nizatidine Monotherapy in Gastritis
NCT05072938Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2021
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Daewoong Pharmaceutical
- Modality
- Small Molecules
- Drugs
- rebamipide
- Conditions
- gastritis
01
Overview
Phase 4, randomised, open-label trial of rebamipide in gastritis (2 arms), sponsored by Daewoong Pharmaceutical. Primary endpoint: Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks. Started Sep 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Nizatidine Monotherapy
Axid Capsule 150mg
Rebamipide/Nizatidine Combination Therapy
Mucotra SR Tablet 150mg + Axid Capsule 150mg
03
Who it enrols
Adult patients aged 19-75 with acute or chronic gastritis diagnosed by endoscopy (at least one erosion) are eligible. Patients with severe liver or kidney disease, malignancies, or other specific GI disorders are excluded.
04
Endpoints
Primary
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
Secondary
Erosion cure rate on upper gastrointestinal endoscopy
Effective rate of bleeding on upper gastrointestinal endoscopy
Effective rate of flares on upper gastrointestinal endoscopy
Edema cure rate on upper gastrointestinal endoscopy
Validity rate of subjective symptom scores evaluated by subjects
Change in total subjective symptom score and individual symptom score
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