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

Helicobacter Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352701
• Other study ID #: CMC-LDS-ILA01
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2015
• Last updated: August 26, 2015
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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

Description:

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

Participants are defined as persons 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. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Subjects participating in a clinical trial before another trial wihin 30 days

• Inconsistence judged subject by researcher

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Helicobacter Infections

Intervention

Drug:
• Noltec tab. 10mg
Ilaprazole 10mg BID dosage form : delayed release tablet
• Chongkundang Amoxicillin Cap. 500mg
Amoxicillin 1000mg, BID dosage form : capsule
• Cravit Tab. 500mg
Levofloxacin 500mg, BID dosage form : film coated tablet

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea Daejeon St.Mary Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events	Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.	Day 49±5	No
Secondary	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	No
Secondary	The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.		Day 49±5	No