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Completed

NCT Number: NCT05656092

A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 19 years to 75 years
  • Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
  • Patients understood the consents and purpose of this trial and signed consent form

Exclusion criteria

  • Patients who cannot perform endoscopy
  • Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
  • History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
  • Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
  • Severe hepatic disease
  • Severe renal disease, CKD
  • Bleeding disorder
  • History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
  • Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
  • Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin
  • Requirement of use of excluded medications during the study
  • History of allergic reaction to the medications used in this study
  • Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
  • Use of other investigational drugs within 30 days prior to the study
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with other reason

Treatment and study plan

HIP0612

Drug

Test drug

HPP2202

Drug

Placebo drug

RLD2204

Drug

Reference drug

HPP2201

Drug

Placebo drug

Primary outcomes

  1. Healing rate of gastric ulcer

    Time frame: week 8

    Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study

Secondary outcomes

  1. Healing rate of gastric ulcer

    Time frame: week 4

  2. Healing rate of gastric ulcer according to H.pylori infection status

    Time frame: week 4, 8

  3. Post-treatment resolution rate of GI symptoms

    Time frame: week 4, 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients With Gastric Ulcer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
Feb 19, 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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