Erosive GastritisPhase 2NCT01578811
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
A Phase 2 study testing SK-MS10 in people with Erosive Gastritis, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Erosive Gastritis
- What is being tested?
- SK-MS10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 2
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
- Patients who voluntarily signed written informed consent may participate in the study.
Who cannot join
- Pregnant or lactating female.
- Patients have gastric ulcer, duodenal ulcer and GERD.
- Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
- Patients requiring corticosteroid therapy
- Severe neurological or psychological disease
- History of allergic reaction to the medications used in this study
- Use of other investigational drugs within 30 days prior to the study.
- Patients that investigators consider ineligible for this study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.
- Conditions
- Erosive Gastritis
- Being tested
- Placebo, SK-MS10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Dosage
SK-MS10Drug
Dosage
SK-MS10Drug
Dosage
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SK-MS10 160mg t.i.d | Experimental | Not described Receives: Drug: SK-MS10 |
| SK-MS10 320mg t.i.d | Experimental | Not described Receives: Drug: SK-MS10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rates of erosive gastritis according to the sydney classification
Measured: Change from Baseline in the grade of erosive gastritis at 2 weeks
Secondary outcomes (6)
Healing rates of erosive gastritis according to the sydney classification
Measured: Change from Baseline in the grade of gastric erosions at 2 weeks
Improvement rates of erosive gastritis by estimated the number of erosion
Measured: Change from Baseline in the number of gastric erosions at 2 weeks
Healing rates of edema according to the sydney classification
Measured: Change from Baseline in the grade of edema at 2 weeks
Improvement rates of erythema according to the sydney classification
Measured: Change from Baseline in the grade of erythema at 2 weeks
Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement
Measured: Change from Baseline in the grade of hemorrhage at 2 weeks
Improvement rates of symptoms using Korean NDI
Measured: Questionaire at baseline and then week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578811
- Sponsor's protocol ID
- SK-MS10_GID_II_2010
- Status last verified
- Dec 2010
- First submitted
- 13 Apr 2012
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
- ClinicalTrials.gov ID
- NCT01578811
- Acronym / sponsor ID
- SK-MS10_GID_II_2010
- Conditions
- Erosive Gastritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Apr 2012 (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 Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SK-MS10 160mg t.i.d | Experimental | Drug: SK-MS10 |
| SK-MS10 320mg t.i.d | Experimental | Drug: SK-MS10 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
- Patients who voluntarily signed written informed consent may participate in the study.
Key exclusion criteria (8 listed)
- Pregnant or lactating female.
- Patients have gastric ulcer, duodenal ulcer and GERD.
- Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
- Patients requiring corticosteroid therapy
- Severe neurological or psychological disease
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 |
|---|---|---|
| PlaceboDosage | Drug | Placebo |
| SK-MS10Dosage | Drug | SK-MS10 160mg t.i.d |
| SK-MS10Dosage | Drug | SK-MS10 320mg t.i.d |
Primary outcome
Improvement rates of erosive gastritis according to the sydney classification
Time frame: Change from Baseline in the grade of erosive gastritis at 2 weeks
6 secondary outcomes
Healing rates of erosive gastritis according to the sydney classification
Time frame: Change from Baseline in the grade of gastric erosions at 2 weeks
Improvement rates of erosive gastritis by estimated the number of erosion
Time frame: Change from Baseline in the number of gastric erosions at 2 weeks
Healing rates of edema according to the sydney classification
Time frame: Change from Baseline in the grade of edema at 2 weeks
Improvement rates of erythema according to the sydney classification
Time frame: Change from Baseline in the grade of erythema at 2 weeks
Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement
Time frame: Change from Baseline in the grade of hemorrhage at 2 weeks
Improvement rates of symptoms using Korean NDI
Time frame: Questionaire at baseline and then week 2
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 18 Mar 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SK-MS10 in people with Erosive Gastritis, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
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 2 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 18 Mar 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 South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Improvement rates of erosive gastritis according to the sydney classification (time frame: Change from Baseline in the grade of erosive gastritis at 2 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 18 Mar 2013.