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Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761512
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Ulcer Drug: CJ-12420 50 mg QD Drug: CJ-12420 100 mg QD Drug: Lansoprazole 30 mg QD Phase 3

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ-12420 50 mg QD
CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: CJ-12420 50 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.
Other Name: Not yet decided

Experimental: CJ-12420 100 mg QD
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: CJ-12420 100 mg QD
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.
Other Name: Not yet decided

Active Comparator: Lansoprazole 30 mg QD
Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks
Drug: Lansoprazole 30 mg QD
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.
Other Name: Lanston cap.




Primary Outcome Measures :
  1. Cumulative healing rate of gastric ulcer at 8-week [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Healing rate of gastric ulcer at 4-week [ Time Frame: 4 weeks ]
  2. Week 8 healing rates by H. pylori infection [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.

Exclusion Criteria:

  1. Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
  2. Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
  3. Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
  4. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
  5. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761512


Locations
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Korea, Republic of
Catholic Univ. Seoul St. Mary Hospita
Seoul, Korea, Republic of
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
HK inno.N Corporation
Investigators
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Principal Investigator: Myung Gyu Choi, M.D., Ph.D Catholic Univ. Seoul St. Mary Hospital
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT02761512    
Other Study ID Numbers: CJ_APA_303
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stomach Ulcer
Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action