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

Tracking Information

• First Submitted Date: January 26, 2011
• First Posted Date: January 27, 2011
• Last Update Posted Date: January 14, 2014
• Study Start Date: February 2011
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 26, 2011): The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group [ Time Frame: 0,4 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2011)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
• 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
• Brief Summary: The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Erosive Gastritis

Intervention

• Drug: Teprenone capsule and placebo of sucralfate
  Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.
• Drug: Sucralfate and placebo of teprenone
  Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks

Study Arms

• Experimental: Teprenone capsule
  Intervention: Drug: Teprenone capsule and placebo of sucralfate
• Active Comparator: sucralfate
  Intervention: Drug: Sucralfate and placebo of teprenone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 13, 2014): 156
• Original Estimated Enrollment (submitted: January 26, 2011): 332
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01284647
• Other Study ID Numbers: 2010-081
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yinchun Zhang, Changhai Hospital
• Study Sponsor: Changhai Hospital
• Collaborators: Eisai China Inc.

Investigators

• Principal Investigator: Zhaoshen Li; Changhai Hospital

• PRS Account: Changhai Hospital
• Verification Date: January 2014