Acute GastritisPhase 4NCT01817556
A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.
A Phase 4 study testing Stillen Tab. and Mucosta Tab. in people with Acute Gastritis and Chronic Gastritis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- Stillen Tab. and Mucosta Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Oct 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is over 20 years old, under 75 years old, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
- Signed the informed consent forms
Who cannot join
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- Patients with surgery related to gastroesophageal
- Patients with Zollinger-Ellison syndrome
- Patients with any kind of malignant tumor
- Patients administered with anti-thrombotic drugs
- Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- Women either pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital, IRB
Seoul, 120-752
About this study
Official title: A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- Stillen Tab., Mucosta Tab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stillen Tab.Drug
Mucosta Tab.Drug
| Study group | Role | What they receive |
|---|---|---|
| Stillen Tab. | Experimental | administered three times daily for four weeks Receives: Drug: Stillen Tab. |
| Mucosta Tab. | Active comparator | administered three times daily for four weeks Receives: Drug: Mucosta Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rates of erosive gastritis
Improvement rates of erosive gastritis (%)
= (improved cases)/(total cases administered) * 100
Measured: 4 weeks
Secondary outcomes (2)
Healing rates of erosive gastritis
Healing rates of erosive gastritis (%)
= (healed cases)/(total cases administered)*100
Measured: 4 weeks
Symptoms improved level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Chan Lee, M.D., Ph.D., Principal investigator, Yonsei University, Severance Hospital of KoreaJin Il Kim, M.D., Ph.D., Principal investigator, The Catholic University, Yeouido St. Mary's Hospital of KoreaKwang Ro Joo, M.D., Ph.D., Principal investigator, Kyung Hee University Gangdong Hospital of KoreaDong Il Park, M.D., Ph.D., Principal investigator, Kangbuk Samsung Hospital of KoreaIn Kyung Sung, M.D.,Ph.D., Principal investigator, Konkuk University Hospital of KoreaKyu Chan Huh, M.D., Ph.D., Principal investigator, Konyang University Hospital of KoreaJung Il Suh, M.D., Ph.D., Principal investigator, Dongguk University Gyeongju Hospital of KoreaSu Jin Hong, M.D., Ph.D., Principal investigator, Soon Chun Hyang University Bucheon Hospital of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817556
- Sponsor's protocol ID
- DA9601_Gas_IV
- Status last verified
- Apr 2021
- First submitted
- 21 Mar 2013
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis
- ClinicalTrials.gov ID
- NCT01817556
- Acronym / sponsor ID
- DA9601_Gas_IV
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Mar 2013 (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 multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.
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 |
|---|---|---|
| Stillen Tab. | Experimental | Drug: Stillen Tab.administered three times daily for four weeks |
| Mucosta Tab. | Active comparator | Drug: Mucosta Tab.administered three times daily for four weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is over 20 years old, under 75 years old, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
- Signed the informed consent forms
Key exclusion criteria (8 listed)
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- Patients with surgery related to gastroesophageal
- Patients with Zollinger-Ellison syndrome
- Patients with any kind of malignant tumor
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 |
|---|---|---|
| Stillen Tab. | Drug | Stillen Tab. |
| Mucosta Tab. | Drug | Mucosta Tab. |
Primary outcome
Improvement rates of erosive gastritis
Time frame: 4 weeks
Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) * 100
2 secondary outcomes
Healing rates of erosive gastritis
Time frame: 4 weeks
Symptoms improved level
Time frame: 4 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 15 Apr 2021.
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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.
Yong Chan Lee, M.D., Ph.D. principal investigator
Yonsei University, Severance Hospital of Korea
Jin Il Kim, M.D., Ph.D. principal investigator
The Catholic University, Yeouido St. Mary's Hospital of Korea
Kwang Ro Joo, M.D., Ph.D. principal investigator
Kyung Hee University Gangdong Hospital of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stillen Tab. and Mucosta Tab. in people with Acute Gastritis and Chronic Gastritis, run by Dong-A ST 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 4 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 15 Apr 2021. 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. 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?
Improvement rates of erosive gastritis (time frame: 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 15 Apr 2021.