A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
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ClinicalTrials.gov Identifier: NCT01284647 |
Recruitment Status :
Completed
First Posted : January 27, 2011
Last Update Posted : January 14, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Erosive Gastritis | Drug: Teprenone capsule and placebo of sucralfate Drug: Sucralfate and placebo of teprenone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 156 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Teprenone capsule |
Drug: Teprenone capsule and placebo of sucralfate
Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks. |
Active Comparator: sucralfate |
Drug: Sucralfate and placebo of teprenone
Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks |
- The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group [ Time Frame: 0,4 weeks ]
- The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group [ Time Frame: 4 weeks ]
- The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group [ Time Frame: 4 weeks ]
- The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group [ Time Frame: 4 and 8 weeks ]
- The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-65 years old
- Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2
- Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)
Exclusion Criteria:
- Suspected upper gastrointestinal malignancy by endoscopy
- Peptic ulcer and bleeding by endoscopy
- Severe cardiac, hepatic or renal insufficiency
- Severe neurological or psychological disease
- Pregnant or lactating women
- Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors 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, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen)
- History of allergic reaction to the medications used in this study
- Patients that investigators consider ineligible for this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284647
China, Beijing | |
Tongren Hospital | |
Beijing, Beijing, China | |
China, Guangdong | |
Zhongshan Hospital of Xiamen University | |
Xiamen, Guangdong, China | |
China, Guangxi | |
First Affiliated Hospital of Guangxi Medical University | |
Nanning, Guangxi, China | |
China, Liaoning | |
First Affiliated Hospital of Dalian Medical University | |
Dalian, Liaoning, China | |
China, Shanghai | |
Changhai Hospital | |
Shanghai, Shanghai, China | |
Shanghai Xinhua Hospital | |
Shanghai, Shanghai, China | |
China, Shanxi | |
First Affiliated Hospital of Shanxi Medical University | |
Taiyuan, Shanxi, China | |
China, Tianjin | |
General Hospital of Tianjin Medical University | |
Tianjin, Tianjin, China |
Principal Investigator: | Zhaoshen Li | Changhai Hospital |
Responsible Party: | Yinchun Zhang, Dr., Changhai Hospital |
ClinicalTrials.gov Identifier: | NCT01284647 |
Other Study ID Numbers: |
2010-081 |
First Posted: | January 27, 2011 Key Record Dates |
Last Update Posted: | January 14, 2014 |
Last Verified: | January 2014 |
Chronic Erosive Gastritis Teprenone Sucralfate |
Gastritis Gastrointestinal Hemorrhage Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Hemorrhage |
Pathologic Processes Disease Attributes Geranylgeranylacetone Sucralfate Anti-Ulcer Agents Gastrointestinal Agents Antineoplastic Agents |