GastritisPhase 4NCT02393430
Clinical Effect of Rebamipide on Chronic Gastritis
A Phase 4 study testing Rebamipide and optimization of life style in people with Gastritis, run by BangMao Wang.
Trial summary
To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastritis
- What is being tested?
- Rebamipide and optimization of life style
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
- diagnosed as chronic gastritis with endoscopic and pathological methods
- agree to join in this clinical trail
Who cannot join
- -
About this study
To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.
- Conditions
- Gastritis
- Being tested
- Rebamipide, optimization of life style
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Also called Mucosta
Rebamipide is a
optimization of life styleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | The experimental group were treated with rebamipide 0.1g tid and optimization of life style. Receives: Drug: Rebamipide; Behavioral: optimization of life style |
| control | Placebo comparator | The control group were only optimized their life style. Receives: Behavioral: optimization of life style |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Lanza score
Measured: 26 weeks
visual Analog scale
to describe the inflamamtory of gastric mucosa pathologically
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- BangMao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BangMao Wang, Tianjin Medical University General Hospital
- Investigators
- Wang Bang-mao, Study chair, Tianjin meidcal university general hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393430
- Sponsor's protocol ID
- GH 0123
- Status last verified
- Mar 2015
- First submitted
- 23 Nov 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Rebamipide on Chronic Gastritis
- ClinicalTrials.gov ID
- NCT02393430
- Acronym / sponsor ID
- GH 0123
- Conditions
- Gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BangMao WangUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Mar 2015 (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.
To investigate the clinical effect of rebamipide in chronic gastritis patients. Patients with chronic gastritis were randomly divided into the experimental group and the control group. The experimental group were treated with rebamipide 0.1g tid and optimization of life style, and the control group were only optimized their life style for 26 weeks. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by modified Lanza score (MLS) and the histology by the updated Sydney system before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Rebamipide, Behavioral: optimization of life styleThe experimental group were treated with rebamipide 0.1g tid and optimization of life style. |
| control | Placebo comparator | Behavioral: optimization of life styleThe control group were only optimized their life style. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- With the symptoms as follow: epigastric pain, abdominal discomfort, abdominal distention, poor appetite, nausea, vomiting and so on
- diagnosed as chronic gastritis with endoscopic and pathological methods
- agree to join in this clinical trail
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| RebamipideAlso: MucostaRebamipide is a | Drug | experimental |
| optimization of life style | Behavioural | control, experimental |
Primary outcome
modified Lanza score
Time frame: 26 weeks
visual Analog scale
Time frame: 26 weeks
to describe the inflamamtory of gastric mucosa pathologically
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 19 Mar 2015.
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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.
Wang Bang-mao study chair
Tianjin meidcal university general hospital,China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebamipide and optimization of life style in people with Gastritis, run by BangMao Wang.
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 1 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
modified Lanza score (time frame: 26 weeks). 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 19 Mar 2015.