NCT01107938

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

50
Monitor

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

1 month

First QC Date

April 19, 2010

Last Update Submit

April 20, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients with healed esophagitis at week 8

    week 8

Secondary Outcomes (2)

  • the proportion of patients healed at week 4

    week 4

  • resolution of clinical symptoms

    week 8

Study Arms (3)

10 mg ilaprazole

EXPERIMENTAL
Drug: 10 mg ilaprazole

15 mg ilaprazole

EXPERIMENTAL
Drug: 15 mg ilaprazole

40 mg esomeprazole

ACTIVE COMPARATOR
Drug: 40 mg esomeprazole

Interventions

10 mg ilaprazoleDRUG

Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks

10 mg ilaprazole
15 mg ilaprazoleDRUG

Three 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks

15 mg ilaprazole
40 mg esomeprazoleDRUG

One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package 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, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig. 2016 Dec;36(12):985-992. doi: 10.1007/s40261-016-0446-3.

    PMID: 27605258DERIVED

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 Officials

  • Sanren Lin, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

  • Liya Zhou, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitang Hu, MD

CONTACT

+86 13892890474wl1020_2000@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Last Updated

April 21, 2010

Record last verified: 2010-04