A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis

• ClinicalTrials.gov Identifier: NCT01284647
• Recruitment Status: Completed
• First Posted: January 27, 2011
• Last Update Posted: January 14, 2014
• Sponsor: Changhai Hospital
• Collaborator: Eisai China Inc.
• Information provided by (Responsible Party): Yinchun Zhang, Changhai Hospital

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group [ Time Frame: 0,4 weeks ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 18-65 years old
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 major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)

Exclusion Criteria:

1. Suspected upper gastrointestinal malignancy by endoscopy
2. Peptic ulcer and bleeding by endoscopy
3. Severe cardiac, hepatic or renal insufficiency
4. Severe neurological or psychological disease
5. Pregnant or lactating women
6. 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)
7. History of allergic reaction to the medications used in this study
8. Patients that investigators consider ineligible for this study

Contacts and Locations

Locations

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

Sponsors and Collaborators

Changhai Hospital

Eisai China Inc.

Investigators

• Principal Investigator: Zhaoshen Li; Changhai Hospital

More Information

• Responsible Party: Yinchun Zhang, Dr., Changhai Hospital
• ClinicalTrials.gov Identifier: NCT01284647
• Other Study ID Numbers: 2010-081
• First Posted: January 27, 2011
• Last Update Posted: January 14, 2014
• Last Verified: January 2014

Keywords provided by Yinchun Zhang, Changhai Hospital:

Chronic Erosive Gastritis; Teprenone; Sucralfate

Additional relevant MeSH terms:

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