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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01860482
Other study ID # 243GERD13003
Secondary ID
Status Completed
Phase Phase 4
First received May 20, 2013
Last updated September 22, 2015
Start date April 2013
Est. completion date May 2015

Study information

Verified date September 2015
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Male or Female aged = 20 years

2. Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.

3. Refractory reflux esophagitis to PPIs standard treatment as follows

1. 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

2. Ongoing heartburn symptom with or without erosion = grade A according to LA Classification

4. Ongoing heartburn symptoms = 2 days during 1week right before administering first dose of IP

5. Decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening

2. History of operation in esophagus, stomach or duodenum

3. The following medical history

1. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm

2. Barrett's esophagus = 3 cm

3. Zollinger-Ellison syndrome

4. Infectious or inflammatory bowel disease, Severe malabsorption

4. Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis

5. History of cancer within 5 years, except completely recovered skin cancer

6. ALT or AST = Upper limit of normal range X 3

7. Need antibiotics due to severe infection

8. 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

9. Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period

10. Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.)

11. Pregnant or breast-feeding women

12. Conversation impairment because of alcohol, drug addiction or mental illness, etc.

13. Administration of other IP within 28 days

14. Inability to record heartburn diary card

15. In investigator's judgement

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Newrabell® Tablet 10mg


Locations

Country Name City State
Korea, Republic of Chonnam National University Hospital Gwangju Donggu, Jebongro
Korea, Republic of Chonnam National University Hwasun Hospital Gwangju Hwasun-eup,Hwasun-gun

Sponsors (1)

Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to onset of first 1Day Heartburn free, Days up to 8 weeks No
Secondary Time to onset of first 2Days Heartburn free, Days up to 8 weeks No
Secondary 1Day Heartburn free days, % up to 8 weeks No
Secondary Time in Daytime of first Heartburn free, Days up to 8 weeks No
Secondary Time in Nighttime of first Heartburn free, Days up to 8 weeks No
Secondary Weekly Heartburn Improvement Rate, % up to 8 weeks No
Secondary Average Daytime and Nighttime Heartburn Score Change at W4 up to 8 weeks No
Secondary Average Daytime and Nighttime Heartburn Score Change at W8 up to 8 weeks No
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