Acute GastritisPhase 4NCT01190657
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
A Phase 4 study testing Selbex in people with Acute Gastritis and Gastric Ulcer, run by Eisai Co., Ltd. at 26 sites in China.
Trial summary
This is a self-controlled, open, multiple-center clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gastritis, Gastric Ulcer
- What is being tested?
- Selbex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,184 participants
- Where
- 26 sitesChina
- Study dates
- May 2010to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is over 18 years old , men or women
- Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
- Signed the informed consent forms.
Who cannot join
- Patients without inclusion criteria
- Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
- Patients with other digestive diseases.
- Patients with operation on stomach and duodenum.
- Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
- Patients with severity trauma, surgery, infection and shock.
- Patients with any kind of tumor
- Women either pregnant or breast feeding
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Chinese People's Liberation Army General Hospital of Beijing Military
Beijing
Chongqing First People's Hospital
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Wuhan Union Hospital
Hubei
Changsha Central Hospital
Hunan
Hunan Provincial People's Hospital
Hunan
Nanjing First Hospital
Jiangsu
Nanjing General Hospital of Nanjing Military Command
Jiangsu
The Second Affiliated Hospital of Nanjing Medical University
Jiangsu
The Second Affiliated Hospital of Suzhou University
Jiangsu
Wuxi #2 People's Hospital
Jiangsu
Jilin University First Hospital
Jilin City
Shengjing Hospital of China Medical University
Liaoning
Shanghai Changzheng Hospital
Shanghai
Shanghai First People's Hospital
Shanghai
Shanghai Renji Hospital
Shanghai
Shanghai Ruijin Hospital
Shanghai
Shanghai Sixth People's Hospital
Shanghai
Shanghai Tenth People's Hospital
Shanghai
Shanxi Provincial People's Hospital
Shanxi
The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University
Shanxi
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Sichuan
The Affiliated Hospital of Luzhou Medical College
Sichuan
Tongji Hospital
Sichuan
Hangzhou Red Cross Hospital
Zhejiang
The First Affiliated Hospital of Zhejiang University
Zhejiang
About this study
Official title: A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
This is a self-controlled, open, multiple-center clinical trial.
- Conditions
- Acute Gastritis, Gastric Ulcer
- Being tested
- Selbex
- Keywords
- Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelbexDrug
50mg/day, 3 times/day, for 14 days
SelbexDrug
50mg/day, 3 times/day, for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Selbex 50mg (14 days) | Experimental | Not described Receives: Drug: Selbex |
| Selbex 50mg (56 days) | Experimental | Not described Receives: Drug: Selbex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic results of ulcer lesion
Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
Measured: 56 days
Total effective rate
Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.
Measured: 56 days.
Secondary outcomes (1)
Symptoms improved level
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastritisStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaozong Yuan, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190657
- Sponsor's protocol ID
- P216
- Status last verified
- Mar 2013
- First submitted
- 26 Aug 2010
- Last updated
- 1 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer
- ClinicalTrials.gov ID
- NCT01190657
- Acronym / sponsor ID
- P216
- Conditions
- Acute Gastritis, Gastric Ulcer
- Keywords
- Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Aug 2010 (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.
This is a self-controlled, open, multiple-center clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selbex 50mg (14 days) | Experimental | Drug: Selbex |
| Selbex 50mg (56 days) | Experimental | Drug: Selbex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age is over 18 years old , men or women
- Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
- Signed the informed consent forms.
Key exclusion criteria (8 listed)
- Patients without inclusion criteria
- Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
- Patients with other digestive diseases.
- Patients with operation on stomach and duodenum.
- Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
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 |
|---|---|---|
| Selbex50mg/day, 3 times/day, for 14 days | Drug | Selbex 50mg (14 days) |
| Selbex50mg/day, 3 times/day, for 56 days | Drug | Selbex 50mg (56 days) |
Primary outcome
Endoscopic results of ulcer lesion
Time frame: 56 days
Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %
Total effective rate
Time frame: 56 days.
Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.
1 secondary outcome
Symptoms improved level
Time frame: 56 days
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 1 Apr 2013.
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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.
Yaozong Yuan principal investigator
Ruijin Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selbex in people with Acute Gastritis and Gastric Ulcer, run by Eisai Co., Ltd. at 26 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 1 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Endoscopic results of ulcer lesion (time frame: 56 days). The study lists 2 primary outcomes in all. 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 1 Apr 2013.