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Efficacy and Safety of HIP1601 Capsule

NCT ID: NCT04080726

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-12-03

Brief Summary

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

Detailed Description

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Conditions

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Erosive Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, randomized, double-blind, parallel group study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blind

Study Groups

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HIP1601+HGP1705 Placebo

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

Group Type EXPERIMENTAL

HIP1601

Intervention Type DRUG

Oral esomeprazole

HGP1705 Placebo

Intervention Type DRUG

Oral Placebo

HGP1705+HIP1601 Placebo

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

Group Type EXPERIMENTAL

HGP1705

Intervention Type DRUG

Oral Nexium Tab

HIP1601 Placebo

Intervention Type DRUG

Oral Placebo

Interventions

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HIP1601

Oral esomeprazole

Intervention Type DRUG

HGP1705

Oral Nexium Tab

Intervention Type DRUG

HIP1601 Placebo

Oral Placebo

Intervention Type DRUG

HGP1705 Placebo

Oral Placebo

Intervention Type DRUG

Other Intervention Names

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esomeprazole Nexium Tab

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hunyong Jung, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 38110901 (View on PubMed)

Other Identifiers

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HM-ESOM-301

Identifier Type: -

Identifier Source: org_study_id