Clinical Trial for GNX80 in Intermittent Claudication

October 24, 2022 updated by: SK Chemicals Co., Ltd.

A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients With Intermittent Claudication

This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Seung-Woon Rha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of at least 20 years
  • Angiographically confirmed peripheral arterial disease
  • Intermittent claudication for more than 6 months

Exclusion Criteria:

  • Severe impairment of heart, liver, or kidney function
  • Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition
  • Poorly controlled diabetes mellitus
  • Positive pregnancy test
  • Planned surgical or endovascular procedures other than for the treatment of IC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GNX
GNX / 80mg / BID / PO
Drug: GNX80
GNX80 oral intake(BID) for 24 weeks
Other Names:
  • Test
Placebo Comparator: Placebo
Placebo / BID / PO
Drug: Placebo
Placebo oral intake(BID) for 24 weeks
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Distance in comparison with the findings from at baseline
Time Frame: 24 weeks
walking distance evaluated by a constant treadmill test
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNX_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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