NCT02401477

Brief Summary

This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

March 24, 2015

Last Update Submit

November 2, 2015

Conditions

Helicobacter Infections

Keywords

helicobacter pyloriilaprazoleeradicationdual therapyhigh dose therapy

Outcome Measures

Primary Outcomes (1)

  • The eradication rate of H.pylori

    The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.

    Day 49±7

Secondary Outcomes (1)

  • The number of patients with Adverse Events

    Day 49±7

Study Arms (1)

Ilaprazole + Amoxicillin

EXPERIMENTAL

Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days

Drug: Ilaprazole + Amoxicillin

Interventions

Ilaprazole + AmoxicillinDRUG

Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule

Also known as: Ilaprazole, Amoxicillin
Ilaprazole + Amoxicillin

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
  • 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(Penicillin Antibiotics).
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • 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
  • Uncontrolled kidney dysfunction
  • Alcoholics
  • Subjects with a history or possibility 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.
  • Infectious mononucleosis patients
  • Subjects participating in a clinical trial before another trial wihin 30 days
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Helicobacter Infections

Interventions

ilaprazoleAmoxicillin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • YoonJeong Lim, MD, PhD

    DongGuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

KR(1)