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Completed

NCT Number: NCT01284647

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongren Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teprenone capsule and placebo of sucralfate

Drug

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

Sucralfate and placebo of teprenone

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Eisai China Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 27, 2011
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.