A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Changhai Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Changhai Hospital
Collaborator:
Eisai China Inc.
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01284647
First received: January 26, 2011
Last updated: July 13, 2011
Last verified: November 2010
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Purpose
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Non-Atrophic Erosive Gastritis |
Drug: Teprenone capsule and placebo of sucralfate Drug: Sucralfate and placebo of teprenone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Changhai Hospital:
Primary Outcome Measures:
- The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group [ Time Frame: 0,4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 332 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 majorm symptoms (epigastric pain, epigastric burning, early satiety, belching) and total sympto 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: PPIs 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, sulcralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, NSAIDs 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284647
Contacts
| Contact: Yiqi Du, Deputy Prof | 86-21-81873247 | duyiqi@hotmail.com |
Locations
| China, Beijing | |
| Chaoyang Hospital | Withdrawn |
| Beijing, Beijing, China | |
| Tongren Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Dongmei Qian | |
| Principal Investigator: Dongmei Qian | |
| China, Guangdong | |
| Zhongshan Hospital of Xiamen University | Not yet recruiting |
| Xiamen, Guangdong, China | |
| Contact: Jianlin Ren | |
| Principal Investigator: Jianlin Ren | |
| China, Guangxi | |
| First Affiliated Hospital of Guangxi Medical University | Not yet recruiting |
| Nanning, Guangxi, China | |
| Contact: Guodu Tang | |
| Principal Investigator: Guodu Tang | |
| China, Liaoning | |
| First Affiliated Hospital of Dalian Medical University | Recruiting |
| Dalian, Liaoning, China | |
| Contact: Yingde Wang | |
| Principal Investigator: Yingde Wang | |
| General Hospital of Shenyang Military Region | Withdrawn |
| Shenyang, Liaoning, China | |
| China, Shanghai | |
| Changhai Hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Yiqi Du duyiqi@hotmail.com | |
| Principal Investigator: Zhaoshen Li | |
| Shanghai Xinhua Hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Jiangao Fan | |
| Principal Investigator: Jiangao Fan | |
| China, Shanxi | |
| First Affiliated Hospital of Shanxi Medical University | Recruiting |
| Taiyuan, Shanxi, China | |
| Contact: Lijuan Huo | |
| Principal Investigator: Lijuan Huo | |
| China, Tianjin | |
| General Hospital of Tianjin Medical University | Recruiting |
| Tianjin, Tianjin, China | |
| Contact: Bangmao Wang | |
| Principal Investigator: Bangmao Wang | |
Sponsors and Collaborators
Changhai Hospital
Eisai China Inc.
Investigators
| Principal Investigator: | Zhaoshen Li | Changhai Hospital |
More Information
No publications provided
| Responsible Party: | Zhaoshen Li, Changhai Hospital |
| ClinicalTrials.gov Identifier: | NCT01284647 History of Changes |
| Other Study ID Numbers: | 2010-081 |
| Study First Received: | January 26, 2011 |
| Last Updated: | July 13, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Changhai Hospital:
|
Chronic Non-Atrophic 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 Sucralfate Geranylgeranylacetone Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013