Reflux EsophagitisPhase 4NCT01860482
The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
A Phase 4 study testing Newrabell® Tablet 10mg in people with Reflux Esophagitis, run by Chong Kun Dang Pharmaceutical at 2 sites in South Korea.
Trial summary
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- Newrabell® Tablet 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2013to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged ≥ 20 years
- Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
- Refractory reflux esophagitis to PPIs standard treatment as follows
- Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss
- Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification
- Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP
- Decided to participate and signed on an informed consent form willingly
Who cannot join
- Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
- History of operation in esophagus, stomach or duodenum
- The following medical history
- Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm
- Barrett's esophagus ≥ 3 cm
- Zollinger-Ellison syndrome
Show all 20Show fewer
- Infectious or inflammatory bowel disease, Severe malabsorption
- Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis
- History of cancer within 5 years, except completely recovered skin cancer
- ALT or AST ≥ Upper limit of normal range X 3
- Need antibiotics due to severe infection
- Severe medical disease that needs these prohibited medication
- Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(>325mg/d), Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids
- Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period
- Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.)
- Pregnant or breast-feeding women
- Conversation impairment because of alcohol, drug addiction or mental illness, etc.
- Administration of other IP within 28 days
- Inability to record heartburn diary card
- In investigator's judgement
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonnam National University Hospital
Gwangju, Donggu, Jebongro, 501-757
Chonnam National University Hwasun Hospital
Gwangju, Hwasun-eup,Hwasun-gun, 519-763
About this study
Official title: An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.
- Conditions
- Reflux Esophagitis
- Being tested
- Newrabell® Tablet 10mg
- Keywords
- Refractory Reflux Esophagitis, GERD, Phase 4
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newrabell® Tablet 10mgDrug
Also called Rabeprazole sodium
| Study group | Role | What they receive |
|---|---|---|
| Newrabell single arm | Experimental | Newrabell® Tablet 10mg b.i.d PO during 8 weeks Receives: Drug: Newrabell® Tablet 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of first 1Day Heartburn free, Days
Measured: up to 8 weeks
Secondary outcomes (7)
Time to onset of first 2Days Heartburn free, Days
Measured: up to 8 weeks
1Day Heartburn free days, %
Measured: up to 8 weeks
Time in Daytime of first Heartburn free, Days
Measured: up to 8 weeks
Time in Nighttime of first Heartburn free, Days
Measured: up to 8 weeks
Weekly Heartburn Improvement Rate, %
Measured: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W4
Measured: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W8
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jongsun Rew, Ph.D, Principal investigator, Chonnam National University HospitalSungbum Cho, Ph.D, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860482
- Sponsor's protocol ID
- 243GERD13003
- Status last verified
- Sep 2015
- First submitted
- 20 May 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen
- ClinicalTrials.gov ID
- NCT01860482
- Acronym / sponsor ID
- 243GERD13003
- Conditions
- Reflux Esophagitis
- Keywords
- Refractory Reflux Esophagitis, GERD, Phase 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 May 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.
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newrabell single arm | Experimental | Drug: Newrabell® Tablet 10mgNewrabell® Tablet 10mg b.i.d PO during 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female aged ≥ 20 years
- Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
- Refractory reflux esophagitis to PPIs standard treatment as follows
- Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP
- Decided to participate and signed on an informed consent form willingly
Key exclusion criteria (20 listed)
- Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
- History of operation in esophagus, stomach or duodenum
- The following medical history
- Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis
- History of cancer within 5 years, except completely recovered skin cancer
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 |
|---|---|---|
| Newrabell® Tablet 10mgAlso: Rabeprazole sodium | Drug | Newrabell single arm |
Primary outcome
Time to onset of first 1Day Heartburn free, Days
Time frame: up to 8 weeks
7 secondary outcomes
Time to onset of first 2Days Heartburn free, Days
Time frame: up to 8 weeks
1Day Heartburn free days, %
Time frame: up to 8 weeks
Time in Daytime of first Heartburn free, Days
Time frame: up to 8 weeks
Time in Nighttime of first Heartburn free, Days
Time frame: up to 8 weeks
Weekly Heartburn Improvement Rate, %
Time frame: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W4
Time frame: up to 8 weeks
Average Daytime and Nighttime Heartburn Score Change at W8
Time frame: up to 8 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 24 Sep 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.
Jongsun Rew, Ph.D principal investigator
Chonnam National University Hospital
Sungbum Cho, Ph.D principal investigator
Chonnam National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Newrabell® Tablet 10mg in people with Reflux Esophagitis, run by Chong Kun Dang Pharmaceutical at 2 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 7 inclusion and 20 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Time to onset of first 1Day Heartburn free, Days (time frame: up to 8 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 24 Sep 2015.