Gastroesophageal Reflux DiseasePhase 3AGSPTNCT01400945
Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease
A Phase 3 study testing AGSPT201 Tab contains S-pantoprazole in people with Gastroesophageal Reflux Disease, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- AGSPT201 Tab contains S-pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Sep 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18~75 years
- Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
- Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
- Symptoms on at least 2 days of the past 7 days
Who cannot join
- PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
- Patients whose history of GI tract resection or vagotomy.
- Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
- Acid irrelevant Heartburn and regurgitation.
- Zollinger Ellison syndrome
- Hypersensitive and/or allergy to Pantoprazole and/or other PPI
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- Pregnancy and lactation
- peptic ulcer
- serious hepatic
- any other renal, cardiac or haematological disease.
- Patients participated any other clinical studies during the past 3 months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea St. Mary's Hospital
Seoul, Seoul, 137040
About this study
Official title: Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
Read the detailed description
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- AGSPT201 Tab contains S-pantoprazole
- Keywords
- GERD, endoscopy, LA grade, heartburn
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGSPT201 Tab contains S-pantoprazoleDrug
Also called AGSPT201 Tab. (Brand name Deflux tab)
comparison of Pantoloc Tab 40mg
| Study group | Role | What they receive |
|---|---|---|
| S-Pantoprazole | Experimental | Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole) Receives: Drug: AGSPT201 Tab contains S-pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions.
Measured: 4 week
Secondary outcomes (1)
Absence and/or improvement of typical reflux symptoms
Patients recorded the improvement of typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation on diary card. The presence of symptoms are classified to absence (Score 0), mild (Score 1), moderate (Score 2), severe (Score 3) and very severe (Score 4).
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MyoungKyu Choi, M.D, Principal investigator, The Catholic University of Korea-St. Mary's HospitalYoungTae Park, M.D., Study director, Korea University Medical Center-GuroPoongRyul Lee, M.D, Study director, Samsung Medical CenterSangKyun Kim, M.D, Study director, Seoul National University HospitalHoonYong Jeong, M.D, Study director, Asan Medical CenterSangYoung Seol, M.D, Study director, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400945
- Sponsor's protocol ID
- AGSPT P3
- Acronym
- AGSPT
- Status last verified
- Sep 2011
- First submitted
- 20 Jul 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
- ClinicalTrials.gov ID
- NCT01400945
- Acronym / sponsor ID
- AGSPT / AGSPT P3
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, endoscopy, LA grade, heartburn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jul 2011 (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 treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
Detailed description
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-Pantoprazole | Experimental | Drug: AGSPT201 Tab contains S-pantoprazoleExperimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18~75 years
- Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification)
- Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month
- Symptoms on at least 2 days of the past 7 days
Key exclusion criteria (11 listed)
- PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing.
- Patients whose history of GI tract resection or vagotomy.
- Barrett's oesophagus greater than 3cm in length and high-grade dysplasia.
- Acid irrelevant Heartburn and regurgitation.
- Zollinger Ellison syndrome
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 |
|---|---|---|
| AGSPT201 Tab contains S-pantoprazoleAlso: AGSPT201 Tab. (Brand name Deflux tab)comparison of Pantoloc Tab 40mg | Drug | S-Pantoprazole |
Primary outcome
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
Time frame: 4 week
Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions.
1 secondary outcome
Absence and/or improvement of typical reflux symptoms
Time frame: 4 week
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 21 Sep 2011.
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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.
MyoungKyu Choi, M.D principal investigator
The Catholic University of Korea-St. Mary's Hospital
YoungTae Park, M.D. study director
Korea University Medical Center-Guro
PoongRyul Lee, M.D study director
Samsung Medical Center
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 AGSPT201 Tab contains S-pantoprazole in people with Gastroesophageal Reflux Disease, run by Ahn-Gook Pharmaceuticals 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 11 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 21 Sep 2011. 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 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?
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions) (time frame: 4 week). 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 21 Sep 2011.