DyspepsiaPhase 3NCT00996788
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
A Phase 3 study testing Rebamipide in people with Dyspepsia and Chronic Gastritis, run by PT Otsuka Indonesia at 1 site in Indonesia.
Trial summary
To study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspepsia, Chronic Gastritis
- What is being tested?
- Rebamipide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2007to Jan 2012
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who
- are 18 - 80 years old
- have symptoms of dyspepsia that need endoscopic examination
- are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
- are able to give informed concern
Who cannot join
- Patients who
- are treated with drugs that induce gastritis/ulcer, such as: NSAID
- are chronic alcoholism,
- are drug abuser
- are contraindicated for endoscopy examination
- has erosive or ulcerative esophagitis
Show all 21Show fewer
- has peptic ulcer that has been confirmed by endoscopy
- has pyloric stenosis
- has active gastrointestinal bleeding
- has major absorption disorder
- has history of gastric surgery
- with renal disorder (creatinine > 2 mg/dL)
- with liver disease ( SGOT, SGPT, bilirubin)
- have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
- are suffering from congestive gastropathy due cirrhosis
- are suffering from congestive heart disease
- are pregnant or giving breast feeding
- are hypersensitive to Rebamipide
- are treated with gastroprotective drugs such as : teprenone, sucralfate.
- are treated with acid suppressing medicine (H2A, PPI)
- are treated with antibiotics, mesalazine (Salofalk)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Jakarta
About this study
To study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
- Conditions
- Dyspepsia, Chronic Gastritis
- Being tested
- Rebamipide
- Keywords
- Patients suffering of dyspepsia due to chronic gastritis
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Rebamipide 100 mg tid for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide | Experimental | Rebamipide 100 mg tid for 28 days Receives: Drug: Rebamipide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
Measured: 2 times (at day-0 and day-28)
Secondary outcomes (1)
To confirm the improvement of dyspepsia syndrome
Measured: 3 times (at day-0, day-7 and day-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Otsuka Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aziz Rani, MD, Principal investigator, Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996788
- Sponsor's protocol ID
- 037-IOB-0701
- Status last verified
- May 2013
- First submitted
- 15 Oct 2009
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
- ClinicalTrials.gov ID
- NCT00996788
- Acronym / sponsor ID
- 037-IOB-0701
- Conditions
- Dyspepsia, Chronic Gastritis
- Keywords
- Patients suffering of dyspepsia due to chronic gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- PT Otsuka IndonesiaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Oct 2009 (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 study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebamipide | Experimental | Drug: RebamipideRebamipide 100 mg tid for 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who
- are 18 - 80 years old
- have symptoms of dyspepsia that need endoscopic examination
- are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
- are able to give informed concern
Key exclusion criteria (21 listed)
- Patients who
- are treated with drugs that induce gastritis/ulcer, such as: NSAID
- are chronic alcoholism,
- are drug abuser
- are contraindicated for endoscopy examination
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 |
|---|---|---|
| RebamipideRebamipide 100 mg tid for 28 days | Drug | Rebamipide |
Primary outcome
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
Time frame: 2 times (at day-0 and day-28)
1 secondary outcome
To confirm the improvement of dyspepsia syndrome
Time frame: 3 times (at day-0, day-7 and day-28)
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 15 May 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.
Aziz Rani, MD principal investigator
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebamipide in people with Dyspepsia and Chronic Gastritis, run by PT Otsuka Indonesia at 1 site in Indonesia.
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 5 inclusion and 21 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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation (time frame: 2 times (at day-0 and day-28)). 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 15 May 2013.