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A Prospective, Randomized, Double-blind, Double-dummy, Sucralfate Controlled, Multicenter Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

A Prospective, Randomized, Double-blind, Double-dummy, Sucralfate Controlled, Multicenter Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001170
Enrollment
Unknown
Registered
2011-01-24
Start date
2011-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic non-atrophic erosive gastritis

Interventions

Group A:teprenone
Group B:none

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18-65y; 2. Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score >=2; 3. Have at least two symptoms in four majorm symptoms (epigastric pain, epigastric burning, early satiety, belching) and total sympto score >=4 (Rome III for Functional Gastrointestinal Disorders).

Exclusion criteria

Exclusion criteria: 1. Suspected upper gastrointestinal malignancy by endoscopy; 2. Peptic ulcer and bleeding by endoscopy; 3. Severe cardiac, hepatic or renal insufficiency,Severe neurological or psychological disease; 4. Pregnant or lactating women; 5. Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: PPIs such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sulcralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, NSAIDs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen); 6. History of allergic reaction to the medications used in this study; 7. Patients that investigators consider ineligible for this study.

Design outcomes

Primary

MeasureTime frame
The difference of the modified Lanza score after 4 weeks;

Secondary

MeasureTime frame
The difference of patients’ gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 week;The difference of total effective rate after 8 weeks treatment evaluated by endoscopy;The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptoms;The difference of total effective rate after 4 weeks treatment evaluated by histologic examination;

Countries

China

Contacts

Public ContactZhaoshen Li
duyiqi@hotmail.com+86 21 81873247

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026