Non Erosive Reflux DiseasePhase 3NCT02274961
S-pantoprazole 10mg Phase III Clinical Study
A Phase 3 study testing S-pantoprazole 10mg in people with Non Erosive Reflux Disease, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 10 sites in South Korea.
Trial summary
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non Erosive Reflux Disease
- What is being tested?
- S-pantoprazole 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Oct 2014to Jul 2015
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 19 and 75 inclusive
- Patient with a history of heartburn or acid regurgitation for at least 3 months.
- Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
- Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
- Capable of providing written informed consent, willing and able to a comply with all procedures of the study
Who cannot join
- History of endoscopic erosive esophagitis(EE) at screening EGD.
- Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
- More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
- Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
- H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
- Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,
- Known hypersensitivity to any component of drug
- pregnancy or lactation (F only)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do
Su-Jin Hong, Professor
- Recruiting
Yeungnam University Medical Center
Daegu, Daegu
Si-Hyung Lee, Professor
- Recruiting
Asan Medical Center
Seoul, Seoul
Hun-Yong Jung, Professor
- Recruiting
Gangnam Severance Hospital
Seoul, Seoul
Hyo-Jin Park, Professor
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul
Ji-Won Kim, Professor
- Recruiting
Seoul National University Hospital
Seoul, Seoul
Sang-Gyun Kim, Professor
- Recruiting
Severance Hospital
Seoul, Seoul
Yong-Chan Lee, Professor
- Recruiting
Seoul St. Mary's Hospital
Seoul
JINHYUNG KIM, 82-2-3289-4362, jhkim04@ahn-gook.com
- Recruiting
Bundang CHA Medical Center
Sung-Nam, Gyeonggi-do
Gwang-Hyun Go, Professor
- Recruiting
Seoul National University Bundang Hospital
Sung-Nam, Gyeonggi-do
Dong-Ho Lee, Professor
About this study
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.
- Conditions
- Non Erosive Reflux Disease
- Being tested
- S-pantoprazole 10mg, Placebo
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-pantoprazole 10mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| S-pantoprazole 10mg | Experimental | S-pantoprazole 10mg Tablet once daily for 4 weeks Receives: Drug: S-pantoprazole 10mg |
| Placebo | Placebo comparator | Placebo tablet for the test drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease
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 posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Erosive 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274961
- Sponsor's protocol ID
- LTP10_KR_1301
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-pantoprazole 10mg Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT02274961
- Acronym / sponsor ID
- LTP10_KR_1301
- Conditions
- Non Erosive Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 27 Oct 2014 (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 clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-pantoprazole 10mg | Experimental | Drug: S-pantoprazole 10mgS-pantoprazole 10mg Tablet once daily for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet for the test drug |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between the ages of 19 and 75 inclusive
- Patient with a history of heartburn or acid regurgitation for at least 3 months.
- Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
- Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
- Capable of providing written informed consent, willing and able to a comply with all procedures of the study
Key exclusion criteria (8 listed)
- History of endoscopic erosive esophagitis(EE) at screening EGD.
- Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
- More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
- Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
- H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
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 |
|---|---|---|
| S-pantoprazole 10mg | Drug | S-pantoprazole 10mg |
| Placebo | Drug | Placebo |
Primary outcome
To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-pantoprazole 10mg in people with Non Erosive Reflux Disease, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 10 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 5 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JINHYUNG KIM, Senior Researcher (82-2-3289-4362, jhkim04@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease (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 27 Oct 2014.