Chronic Erosive GastritisPhase 4NCT01284647
A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
A Phase 4 study of Chronic Erosive Gastritis, run by Changhai Hospital at 8 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Erosive Gastritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 8 sitesChina
- Study dates
- Feb 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Tongren Hospital
Beijing, Beijing Municipality
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Changhai Hospital
Shanghai, Shanghai Municipality
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Zhongshan Hospital of Xiamen University
Xiamen, Guangdong
About this study
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
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
- Being tested
- Teprenone capsule and placebo of sucralfate, Sucralfate and placebo of teprenone
- Keywords
- Chronic Erosive Gastritis, Teprenone, Sucralfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teprenone capsule and placebo of sucralfateDrug
Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.
Sucralfate and placebo of teprenoneDrug
Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Teprenone capsule | Experimental | Not described Receives: Drug: Teprenone capsule and placebo of sucralfate |
| sucralfate | Active comparator | Not described Receives: Drug: Sucralfate and placebo of teprenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
Measured: 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
Measured: 4 weeks
The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group
Measured: 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
Measured: 4 and 8 weeks
The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Erosive GastritisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai China Inc.
- Responsible party
- Principal investigator, Yinchun Zhang, Changhai Hospital
- Investigators
- Zhaoshen Li, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284647
- Sponsor's protocol ID
- 2010-081
- Status last verified
- Jan 2014
- First submitted
- 26 Jan 2011
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01284647
- Acronym / sponsor ID
- 2010-081
- Conditions
- Chronic Erosive Gastritis
- Keywords
- Chronic Erosive Gastritis, Teprenone, Sucralfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Eisai China Inc.
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teprenone capsule | Experimental | Drug: Teprenone capsule and placebo of sucralfate |
| sucralfate | Active comparator | Drug: Sucralfate and placebo of teprenone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teprenone capsule and placebo of sucralfateTeprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks. | Drug | Teprenone capsule |
| Sucralfate and placebo of teprenonePlacebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks | Drug | sucralfate |
Primary outcome
The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
Time frame: 0,4 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li principal investigator
Changhai Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Chronic Erosive Gastritis, run by Changhai Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group (time frame: 0,4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.