Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)
Condition: Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

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
      four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of
      ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 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.
    

Detailed description: 
      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. Stages of the
      ulcers were endoscopically assessed according to the degree of ulceration, regenerating
      epithelialization, and scarring, which was defined as follows: A stage (active stage, A1 &
      A2) where A1 stage is more severe than A2 stage, H stage (healing stage, H1 & H2) where H2
      stage is better than H1 stage, and S stage (scarring stage, S1 (red scar) & S2 (white scar))
      where S stage is the best stage in the three stages and S2 stage is better than S1.Healing of
      ulcer is deemed successful if an ulcer in A stage resolved to S stage at the end of the
      treatment period, regardless of S1 or S2. When endoscopy demonstrated successful ulcer
      healing, study medication was discontinued. Patients returned at week 2, and if unhealed
      further endoscopic assessment would be done at week 4. Secondary endpoints included
      post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain,
      heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus. These
      symptoms were recorded on a scale ranging from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe)
      at baseline, week 1, 2, and 4. Resolution of symptoms were defined as "excellence",
      "effective", "improved", or "ineffective" relative to baseline levels, of which complete
      symptom relief or complete absence of the symptom without recurrence was deemed as
      "excellence". Safety assessments based mainly on the occurrence, frequency, and severity of
      adverse events, which were monitored throughout the duration of the study, and also based on
      comprehensive indexes, including physical examination, electrocardiography, and routine
      laboratory investigations, which were performed at baseline and repeated at the end of the
      treatment period. For all adverse events, where necessary, patients were withdrawn from the
      study.
    

Intervention name(s): 5 mg ilaprazole; 10 mg ilaprazole; 20 mg ilaprazole; 20 mg omeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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 morning on an empty stomach for 4 weeks; 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; Four 5-mg ilaprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks; One 20-mg omeprazole capsule (AstraZeneca, Losec) together with four placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
Other intervention name(s): Losec,AstraZeneca
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ilaprazole; Proton pump inhibitor; Duodenal ulcer; Acid suppression; Randomized trial