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

NCT01284647 | Completed Phase 4 DMC

• 1 other identifier: 2010-081
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Chronic Erosive Gastritis

Keywords

Chronic Erosive Gastritis; Teprenone; Sucralfate

Outcome Measures

Primary Outcomes (1)

• The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group

  0,4 weeks

Secondary Outcomes (4)

• The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group

  4 weeks

• The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group

  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

  4 and 8 weeks

• The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group

  8 weeks

Study Arms (2)

Teprenone capsule

EXPERIMENTAL

Drug: Teprenone capsule and placebo of sucralfate

sucralfate

ACTIVE COMPARATOR

Drug: Sucralfate and placebo of teprenone

Interventions

Teprenone capsule and placebo of sucralfate DRUG

Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.

Teprenone capsule

Sucralfate and placebo of teprenone DRUG

Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks

sucralfate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Eisai China Inc.: collaborator

Study Sites (8)

Tongren Hospital

Beijing, Beijing Municipality, China

Location

Zhongshan Hospital of Xiamen University

Xiamen, Guangdong, China

Location

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, China

Location

First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

geranylgeranylacetone; Sucralfate

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Zhaoshen Li

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CN (8)