Health TrialsbyHealthPanel

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

ConditionPeptic Ulcer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorIl-Yang Pharm. Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ilaprazole

    Drug

    Ilaprazole 10 mg

  • Lansoprazole

    Drug

    Lansoprazole 15 mg

  • Ilaprazole Placebo

    Drug

    Placebo of Ilaprazole 10 mg

  • Lansoprazole Placebo

    Drug

    Placebo of Lansoprazole 15 mg

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: Ilaprazole 10 mgExperimental treatment 2 interventions
Group B: Lansoprazole 15 mgActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Ilaprazole, Lansoprazole peptic ulcer

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

Time frame
at 24 weeks

Secondary outcomes

1

Ilaprazole, Lansoprazole peptic ulcer

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

Time frame
at 12 weeks
2

Ilaprazole, Lansoprazole GI bleeding

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

Time frame
at 12, 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Il-Yang Pharm. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now