A Phase 3 interventional study of CJ-12420 50 mg QD and CJ-12420 100 mg QD in Gastric Ulcer, sponsored by HK inno.N Corporation. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by HK inno.N Corporation · Phase 3, Interventional, and Treatment
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 306 is above the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: CJ-12420 50 mg QD
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: CJ-12420 100 mg QD
Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
Drug: Lansoprazole 30 mg QD
CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.
Also known as: Not yet decided
CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.
Also known as: Not yet decided
Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.
Also known as: Lanston cap.
Cumulative healing rate of gastric ulcer at 8-week
Time frame: 8 weeks
Healing rate of gastric ulcer at 4-week
Time frame: 4 weeks
Week 8 healing rates by H. pylori infection
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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HK inno.N Corporation