Efficacy and Safety of HIP1601 Capsule

NCT04080726 | Completed Phase 3

• 1 other identifier: HM-ESOM-301
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erosive Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Complete healing rate

  percentage of subjects whose erosion is completely cured

  at 4 weeks or 8 weeks

Secondary Outcomes (7)

• Complete healing rate

  at 4 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 heartburn, acid regurgitation

  at 4 weeks or 8 weeks

Study Arms (2)

HIP1601+HGP1705 Placebo

EXPERIMENTAL

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

Drug: HIP1601; Drug: HGP1705 Placebo

HGP1705+HIP1601 Placebo

EXPERIMENTAL

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

Drug: HGP1705; Drug: HIP1601 Placebo

Interventions

HIP1601 DRUG

Oral esomeprazole

Also known as: esomeprazole

HIP1601+HGP1705 Placebo

HGP1705 DRUG

Oral Nexium Tab

Also known as: Nexium Tab

HGP1705+HIP1601 Placebo

HIP1601 Placebo DRUG

Oral Placebo

HGP1705+HIP1601 Placebo

HGP1705 Placebo DRUG

Oral Placebo

HIP1601+HGP1705 Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Lim H, Park JK, Chung H, Lee SH, Park JM, Park JH, Kim GH, Shin SK, Hong SJ, Lee KJ, Park MI, Jung HK, Kim HS, Sung JK, Jeon SW, Choi SC, Moon JS, Kim N, Park JJ, Hong SH, Kim NY, Jung HY. Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study. BMC Gastroenterol. 2023 Dec 18;23(1):447. doi: 10.1186/s12876-023-03087-6.

  PMID: 38110901 DERIVED

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hunyong Jung, MD, Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, double-blind, parallel group study

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: October 25, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

KR (1)