Clinical trial NCT01860482: The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Reflux Esophagitis
Keywords: Refractory Reflux Esophagitis
GERD
Phase 4
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to onset of first 1Day Heartburn free, Days
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Time to onset of first 2Days Heartburn free, Days
timeFrame: up to 8 weeks
measure: 1Day Heartburn free days, %
timeFrame: up to 8 weeks
measure: Time in Daytime of first Heartburn free, Days
timeFrame: up to 8 weeks
measure: Time in Nighttime of first Heartburn free, Days
timeFrame: up to 8 weeks
measure: Weekly Heartburn Improvement Rate, %
timeFrame: up to 8 weeks
measure: Average Daytime and Nighttime Heartburn Score Change at W4
timeFrame: up to 8 weeks
measure: Average Daytime and Nighttime Heartburn Score Change at W8
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Donggu, Jebongro
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Hwasun-eup,Hwasun-gun
Study officials:
affiliation: Chonnam National University Hospital
name: Jongsun Rew, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Sungbum Cho, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: