NCT02847455

Brief Summary

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into three groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of ilaprazole, 5, 10 mg/day, and one of Rabeprazole 10 mg/day as positive control. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for phase_2

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

August 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

July 25, 2016

Last Update Submit

July 25, 2016

Conditions

Duodenal Ulcer

Keywords

IlaprazoleProton pump inhibitorDuodenal ulcerAcid suppressionRandomized trial

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels.

    week 4

Secondary Outcomes (1)

  • Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus.

    week 4

Study Arms (3)

5 mg ilaprazole

EXPERIMENTAL
Drug: 5 mg ilaprazole

10 mg ilaprazole

EXPERIMENTAL
Drug: 10 mg ilaprazole

10mg Rabeprazole

ACTIVE COMPARATOR
Drug: 10 mg Rabeprazole

Interventions

5 mg ilaprazoleDRUG

One 5-mg ilaprazole tablet (Livzon Pharm Group Inc., China) together with three placebo tablets and one placebo capsule in a package being taken orally each

5 mg ilaprazole
10 mg ilaprazoleDRUG

Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with two placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks

10 mg ilaprazole
10 mg RabeprazoleDRUG

one 10-mg Rabeprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks

10mg Rabeprazole

Eligibility Criteria

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

You may qualify if:

  • \- Consenting patients were eligible for enrollment if they:
  • were 18-65 years of age,
  • had endoscopically diagnosed active duodenal ulcers within the previous 72 hours,
  • the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.

You may not qualify if:

  • \- Patients were ineligible if they:
  • had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
  • had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
  • had severe complications (e.g., pyloric obstruction, active bleeding under endoscope), severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
  • were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
  • had 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,
  • had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
  • had alcoholic intemperance, drug addiction or any other improper habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ni H, Shi J, Hu M, Zhou N, Yang S. Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. Front Pharmacol. 2024 Jun 7;15:1407435. doi: 10.3389/fphar.2024.1407435. eCollection 2024.

    PMID: 38910891DERIVED

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

ilaprazoleRabeprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

August 1, 2008

Primary Completion

October 1, 2009

Last Updated

July 28, 2016

Record last verified: 2016-07