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CompletedNCT01284647Updated Jan 14, 2014

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

A Phase 4 interventional study of Teprenone capsule and placebo of sucralfate and Sucralfate and placebo of teprenone in Chronic Erosive Gastritis, sponsored by Changhai Hospital. Completed at 8 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-14.

Sponsored by Changhai Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Erosive Gastritis

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Keywords

  • Chronic Erosive Gastritis
  • Teprenone
  • Sucralfate
03

In context

Gastritis

197 studies on the registry are indexed under Gastritis; 43 are open to participants now.

This study's enrollment of 156 is below the median of 200 across 113 interventional studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    Teprenone capsule

    Drug: Teprenone capsule and placebo of sucralfate

  • Active comparator
    sucralfate

    Drug: Sucralfate and placebo of teprenone

Interventions

  • DrugTeprenone capsule and placebo of sucralfate

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

  • DrugSucralfate and placebo of teprenone

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

06

What researchers measure

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

07

Study locations

8 sites
  • Tongren Hospital
    Beijing, Beijing, China
  • Zhongshan Hospital of Xiamen University
    Xiamen, Guangdong, China
  • First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi, China
  • First Affiliated Hospital of Dalian Medical University
    Dalian, Liaoning, China
  • Changhai Hospital
    Shanghai, Shanghai, China
  • Shanghai Xinhua Hospital
    Shanghai, Shanghai, China
  • First Affiliated Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
  • General Hospital of Tianjin Medical University
    Tianjin, Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01284647
Lead sponsor
Changhai Hospital
Collaborators
Eisai China Inc.
Responsible party
Yinchun Zhang (Dr., Changhai Hospital) — Principal investigator
First posted
Jan 27, 2011
Start date
Feb 2011
Primary completion
Oct 2012
Completion
Jun 2013
Last update
Jan 14, 2014

Study contacts

Zhaoshen Li
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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