Efficacy and Safety of HIP1601 Capsule

Phase 3

Completed

• Conditions: Erosive Gastroesophageal Reflux Disease
• Interventions: Drug: HGP1705; Drug: HIP1601; Drug: HGP1705 Placebo; Drug: HIP1601 Placebo

• Registration Number: NCT04080726
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• 19≤ age ≤ 75
• Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
• Patients experienced heartburn or acid regurgitation within 7 days of screening day
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria

• Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
• Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
• Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
• Uncontrolled diabetes mellitus
• Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
• Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIP1601+HGP1705 Placebo	HGP1705 Placebo	HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
HGP1705+HIP1601 Placebo	HGP1705	HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
HGP1705+HIP1601 Placebo	HIP1601 Placebo	HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
HIP1601+HGP1705 Placebo	HIP1601	HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks

Primary Outcome Measures

Name	Time	Method
Complete healing rate	at 4 weeks or 8 weeks	percentage of subjects whose erosion is completely cured

Secondary Outcome Measures

Name	Time	Method
Complete healing rate	at 4 weeks	percentage of subjects whose erosion is completely cured
Time to sustained resolution heartburn, acid regurgitation	at 4 weeks or 8 weeks
Complete resolution rate of each symptom in GERD	at 4,8 weeks
Proportion of heartburn-free days, acid regurgitation-free days	at 1, 2, 4, 8 weeks
Proportion of heartburn-free nights, acid regurgitation-free nights	at 1, 2, 4, 8 weeks
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation	at 4 weeks or 8 weeks
Total number of use of relief drugs and average usage per day	at 4 weeks or 8 weeks

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of