Efficacy and Safety of HIP1601 Capsule

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Erosive Gastroesophageal Reflux Disease

Treatments: Drug: HGP1705; Drug: HIP1601 Placebo; Drug: HIP1601; Drug: HGP1705 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04080726

HM-ESOM-301

Details and patient eligibility

About

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

Enrollment: 213 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 2 patient groups

HIP1601+HGP1705 Placebo

Experimental group

Description:

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

Treatment:

Drug: HIP1601

Drug: HGP1705 Placebo

HGP1705+HIP1601 Placebo

Experimental group

Description:

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

Treatment:

Drug: HIP1601 Placebo

Drug: HGP1705