NCT02860624

Brief Summary

This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for phase_3

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, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

July 26, 2016

Last Update Submit

August 8, 2016

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

  • Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.

    week 8

Study Arms (2)

10 mg ilaprazole

EXPERIMENTAL
Drug: 10 mg ilaprazole

40 mg esomeprazole

ACTIVE COMPARATOR
Drug: 40mg esomeprazole

Interventions

10 mg ilaprazoleDRUG

Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks

10 mg ilaprazole
40mg esomeprazoleDRUG

One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks

40 mg esomeprazole

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting patients will be eligible for enrollment if they:
  • are 18-70 years of age,
  • have at least one of the two symptoms, heartburn and reflux,
  • have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

You may not qualify if:

  • Patients will be ineligible if they:
  • have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
  • have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
  • have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
  • have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
  • participated in a clinical trial with an investigational drug or device within the past three months,
  • have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
  • have alcoholic intemperance, drug addiction or any other improper habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.

    PMID: 29540336DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

ilaprazoleEsomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 9, 2016

Study Start

December 1, 2011

Primary Completion

April 1, 2013

Last Updated

August 9, 2016

Record last verified: 2016-07