GastritisPhase 2NCT02353039
Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
A Phase 2 study testing GC6101A 37.5mg, GC6101A 75mg and GC6101A 150mg in people with Gastritis, run by Green Cross Corporation at 14 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastritis
- What is being tested?
- GC6101A 37.5mg, GC6101A 75mg and GC6101A 150mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Sep 2014to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is over 19 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 who is impossible to receive gastroscopy
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy)
- Patients with esophageal varix
- Patients with malignant neoplasm of gastrointestinal tract
- Patients with thrombosis or administered with anti-thrombotic drugs
Show all 15Show fewer
- Patients with consumption coagulopathy
- Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks
- Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment
- Allergic or hypersensitive to any of the ingredients in the test products
- Pregnant or lactating female
- Patients who have abnormal baseline laboratory test result
- Patients taking other investigational drugs within 30 days prior to the study.
- Patients with Zollinger-Ellison syndrome
- Patients that investigators consider ineligible for this study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites, 14 recruiting
- Recruiting
Inje University, Busan Paik Hospital of Korea
Busan
Sam Ryong Ji, M.D. Ph.D., tokimom@nate.com
Sam Ryong Ji, M.D. Ph.D.
- Recruiting
Keimyung University, Dongsan Medical Center of Korea
Daegu
Gyeong Sik Park, M.D. Ph.D., seenae99@dsmc.or.kr
Gyeong Sik Park, M.D. Ph.D.
- Recruiting
Wonkwang University, Hospital of Korea
Iksan-si
Seok Chae Choi, M.D. Ph.D., medcsc@wonkwang.ac.kr
Seok Chae Choi, M.D. Ph.D.
- Recruiting
Seoul National University, Bundang Hospital of Korea
Seongnam-si
Na Yeong Kim, M.D. Ph.D., nayoungkim49@empal.com
Na Yeong Kim, M.D. Ph.D.
- Recruiting
Chungang University, Hospital of Korea
Seoul
Jae Gyu Kim, M.D. Ph.D., jgkimd@cau.ac.kr
Jae Gyu Kim, M.D. Ph.D.
- Recruiting
Ewha Womans University, Medical Center of Korea
Seoul
Hye Kyung Jung, M.D. Ph.D., junghk@ewha.ac.kr
Hye Kyung Jung, M.D. Ph.D.
- Recruiting
Inje University, Seoul Paik Hospital of Korea
Seoul
Jeong Seop Moon, M.D. Ph.D., moonjs2@unitel.co.kr
Jeong Seop Moon, M.D. Ph.D.
- Recruiting
Kankbuk Samsung Medical Center of Korea
Seoul
Jeong Ho Park, M.D. Ph.D., pjho3@hotmail.com
Jeong Ho Park, M.D. Ph.D.
- Recruiting
Korea University, Guro Hospital of Korea
Seoul
Jong Jae Park, M.D. Ph.D., gi7pjj@yahoo.co.kr
Jong Jae Park, M.D. Ph.D.
- Recruiting
Seoul National University, Hospital of Korea
Seoul
Sang Gyun Kim, M.D. Ph.D., harley1333@hanmail.net
Sang Gyun Kim, M.D. Ph.D.
- Not yet recruiting
Soonchunhyang University, Seoul Hospital of Korea
Seoul
Jun Seong Lee, M.D. Ph.D., joonlee@schmc.ac.kr
Jun Seong Lee, M.D. Ph.D.
- Recruiting
The Catholic University, Seoul St. Mary's Hospital of Korea
Seoul
Jae Myeong Park, M.D. Ph.D., parkjerry@catholic.ac.kr
Jae Myeong Park, M.D. Ph.D.
- Recruiting
Yonsei University, Gangnam Severance Hospital of Korea
Seoul
Hyo Jin Park, M.D. Ph.D., hjpark21@yuhs.ac
Hyo Jin Park, M.D. Ph.D.
- Recruiting
Ajou University, Medical Center of Korea
Suwon
Gwang Jae Lee, M.D. Ph.D., kjleemd@hotmail.com
Gwang Jae Lee, M.D. Ph.D.
About this study
Official title: Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.
Read the detailed description
GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.
- Conditions
- Gastritis
- Being tested
- GC6101A 37.5mg, GC6101A 75mg, GC6101A 150mg, Placebo
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC6101A 37.5mgDrug
Administer 12.5mg of GC6101A t.i.d for 2 weeks.
GC6101A 75mgDrug
Administer 25mg of GC6101A t.i.d for 2 weeks.
GC6101A 150mgDrug
Administer 50mg of GC6101A t.i.d for 2 weeks.
PlaceboDrug
Administer placebo t.i.d for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| GC6101A 37.5mg | Experimental | Administer 12.5mg of GC6101A t.i.d for 2 weeks. Receives: Drug: GC6101A 37.5mg |
| GC6101A 75mg | Experimental | Administer 25mg of GC6101A t.i.d for 2 weeks. Receives: Drug: GC6101A 75mg |
| GC6101A 150mg | Experimental | Administer 50mg of GC6101A t.i.d for 2 weeks. Receives: Drug: GC6101A 150mg |
| Placebo | Placebo comparator | Administer placebo t.i.d for 2 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
Measured: 2 weeks
Secondary outcomes (9)
A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
The definition of "significant improvement" is the subject showed score changed from 2-4 to 1.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
Measured: 2 weeks
A percentage of subjects showed improvement of edema rating scale
The definition of "improvement" is the subjects showed score changed from 2 to 1.
Measured: 2 weeks
A percentage of subjects showed improvement of erythema rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Measured: 2 weeks
A percentage of subjects showed improvement of hemorrhage rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Measured: 2 weeks
A percentage of subjects showed improvement of gastric symptom rating scale
The definition of "improvement" is the subjects showed reduction ratio of score changed 50% or more.
Measured: 2 weeks
Adverse Events
Measured: 2 weeks
Lab results(Hematology, Blood chemistry, Urinalysis)
Measured: 2 weeks
The results of physical examinations and Vital signs(body temperature, pulse)
Measured: 2 weeks
EKG results
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc., CRScube
- Responsible party
- Sponsor
- Investigators
- Hyo Jin Park, MD, Ph.D, Principal investigator, Yonsei University, Gangnam Severance Hospital of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353039
- Sponsor's protocol ID
- GC6101A_P2
- Status last verified
- Jul 2015
- First submitted
- 27 Jan 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Multicenter, Randomized, Placebo-controlled, Parallel-group, Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis
- ClinicalTrials.gov ID
- NCT02353039
- Acronym / sponsor ID
- GC6101A_P2
- Conditions
- Gastritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- C&R Research, Inc., CRScube
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 2 Feb 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.
The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.
Detailed description
GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GC6101A 37.5mg | Experimental | Drug: GC6101A 37.5mgAdminister 12.5mg of GC6101A t.i.d for 2 weeks. |
| GC6101A 75mg | Experimental | Drug: GC6101A 75mgAdminister 25mg of GC6101A t.i.d for 2 weeks. |
| GC6101A 150mg | Experimental | Drug: GC6101A 150mgAdminister 50mg of GC6101A t.i.d for 2 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboAdminister placebo t.i.d for 2 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is over 19 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 (15 listed)
- Patients who is impossible to receive gastroscopy
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy)
- Patients with esophageal varix
- Patients with malignant neoplasm of gastrointestinal tract
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 |
|---|---|---|
| GC6101A 37.5mgAdminister 12.5mg of GC6101A t.i.d for 2 weeks. | Drug | GC6101A 37.5mg |
| GC6101A 75mgAdminister 25mg of GC6101A t.i.d for 2 weeks. | Drug | GC6101A 75mg |
| GC6101A 150mgAdminister 50mg of GC6101A t.i.d for 2 weeks. | Drug | GC6101A 150mg |
| PlaceboAdminister placebo t.i.d for 2 weeks | Drug | Placebo |
Primary outcome
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy
Time frame: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 2-4 to 1 or from 4 to 2. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
9 secondary outcomes
A percentage of subjects showed significant improvement of stomach erosions by the endoscopy
Time frame: 2 weeks
A percentage of subjects showed improvement of edema rating scale
Time frame: 2 weeks
A percentage of subjects showed improvement of erythema rating scale
Time frame: 2 weeks
A percentage of subjects showed improvement of hemorrhage rating scale
Time frame: 2 weeks
A percentage of subjects showed improvement of gastric symptom rating scale
Time frame: 2 weeks
Adverse Events
Time frame: 2 weeks
Lab results(Hematology, Blood chemistry, Urinalysis)
Time frame: 2 weeks
The results of physical examinations and Vital signs(body temperature, pulse)
Time frame: 2 weeks
EKG results
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Hyo Jin Park, MD, Ph.D principal investigator
Yonsei University, Gangnam Severance Hospital of Korea
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC6101A 37.5mg, GC6101A 75mg and GC6101A 150mg in people with Gastritis, run by Green Cross Corporation at 14 sites 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 15 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: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Min Kim, B.S. (+82-31-260-1936, dreamerkdm@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A percentage of subjects showed moderate improvement of stomach erosions by the endoscopy (time frame: 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 3 Jul 2015.