Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newrabell single arm | Experimental | Newrabell® Tablet 10mg b.i.d PO during 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newrabell® Tablet 10mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of first 1Day Heartburn free, Days | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of first 2Days Heartburn free, Days | up to 8 weeks | |
| 1Day Heartburn free days, % | up to 8 weeks | |
| Time in Daytime of first Heartburn free, Days |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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
ALT or AST ≥ Upper limit of normal range X 3
Need antibiotics due to severe infection
Severe medical disease that needs these prohibited medication
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jongsun Rew, Ph.D | Chonnam National University Hospital | Principal Investigator |
| Sungbum Cho, Ph.D | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | Donggu, Jebongro | 501-757 | South Korea | ||
| Chonnam National University Hwasun Hospital |
Not provided
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 8 weeks |
| Time in Nighttime of first Heartburn free, Days | up to 8 weeks |
| Weekly Heartburn Improvement Rate, % | up to 8 weeks |
| Average Daytime and Nighttime Heartburn Score Change at W4 | up to 8 weeks |
| Average Daytime and Nighttime Heartburn Score Change at W8 | up to 8 weeks |
| Gwangju |
| Hwasun-eup,Hwasun-gun |
| 519-763 |
| South Korea |
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |