The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD

Reflux Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860482
• Other study ID #: 243GERD13003
• 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

• Esophagitis
• Esophagitis, Peptic
• Reflux Esophagitis

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