Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori

NCT02352701 | Completed DMC

• 1 other identifier: CMC-LDS-ILA01
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori

Conditions

Helicobacter Infections

Keywords

helicobacter pylori; ilaprazole; eradication; triple therapy

Outcome Measures

Primary Outcomes (1)

• The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy

  The eradication rate of H.pylori after 10 days treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days

  Day 49±5

Secondary Outcomes (3)

• The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events

  Day 49±5

• The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.

  Day 49±5

• The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.

  Day 49±5

Study Arms (1)

Noltec®,ChongkundangAmoxicillin®,Cravit®

Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days

Drug: Noltec tab. 10mg; Drug: Chongkundang Amoxicillin Cap. 500mg; Drug: Cravit Tab. 500mg

Interventions

Noltec tab. 10mg DRUG

Ilaprazole 10mg BID dosage form : delayed release tablet

Also known as: Ilaprazole

Noltec®,ChongkundangAmoxicillin®,Cravit®

Chongkundang Amoxicillin Cap. 500mg DRUG

Amoxicillin 1000mg, BID dosage form : capsule

Also known as: Amoxicillin

Noltec®,ChongkundangAmoxicillin®,Cravit®

Cravit Tab. 500mg DRUG

Levofloxacin 500mg, BID dosage form : film coated tablet

Also known as: Levofloxacin

Noltec®,ChongkundangAmoxicillin®,Cravit®

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the hospital

You may qualify if:

• Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
• Subject who fully understands conditions of clinical trial.
• Subject who agrees to participate and spontaneously sign the ICF

You may not qualify if:

• Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
• Subjects who are taking contraindicated medications for experimental and concomitant drug.
• Patients with abnormal levels in the laboratory tests
• Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
• AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal
• Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
• Pregnant and/or lactating women
• Reproductive aged women not using contraception
• Uncontrolled diabetics
• Uncontrolled hypertension
• Uncontrolled liver dysfunction
• Alcoholics
• Subjects with a history of digestive malignancy within 5 years
• Subjects with a history of gastrectomy or esophagectomy
• Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

The Catholic Univ. of Korea Daejeon St.Mary Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Helicobacter Infections

Interventions

ilaprazole; Amoxicillin; Levofloxacin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Dongsoo Lee, MD, PhD.

  The Catholic Univ. of Korea, Daejeon St.Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 2, 2015
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

KR (1)