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NCT Number: NCT06284876

Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung Ang University Hospital, Seoul, South Korea

Loading trial locations.

About this study

Not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males and females aged 19 years or older on the day of informed consent
  • Subjects requiring continuous treatment or receiving treatment with NSAIDs
  • Subjects with at least one of following peptic ulcer risk factors at the time of Screening
  • Subjects who have provided voluntary informed consent for the study participation after the study is explained

Exclusion criteria

  • Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
  • Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
  • Subjects with confirmed history of malignancy within 5 years prior to Screening
  • Positive human immunodeficiency virus (HIV) antigen/antibody at Screening

Treatment and study plan

Ilaprazole

Drug

Ilaprazole 10 mg

Other names: Noltec(the brand name)

Lansoprazole

Drug

Lansoprazole 15 mg

Other names: Lanston(the brand name)

Ilaprazole Placebo

Drug

Placebo of Ilaprazole 10 mg

Other names: Ilaprazole Placebo-matching tablet

Lansoprazole Placebo

Drug

Placebo of Lansoprazole 15 mg

Other names: Lansoprazole Placebo-matching tablet

Primary outcomes

  1. Ilaprazole, Lansoprazole peptic ulcer

    Time frame: at 24 weeks

    Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment

Secondary outcomes

  1. Ilaprazole, Lansoprazole peptic ulcer

    Time frame: at 12 weeks

    Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment

  2. Ilaprazole, Lansoprazole GI bleeding

    Time frame: at 12, 24 weeks

    Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment

Study contacts

Contact information is provided by the study sponsor or research team.

JeongSu Wi, bachelor

CONTACT

[email protected]

+82.2.570.3778

JungHwa Hong, Master

CONTACT

[email protected]

+82.2.570.3777

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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