Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia (CPC2)

September 30, 2021 updated by: Sun Gun Chung, Seoul National University Hospital

Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks, four weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University College of Medicine

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2

Exclusion Criteria:

  • History of stroke or spinal cord injury
  • Artificial joint
  • Acute disease or unstable chronic disease
  • Phenylketonuria
  • History of myocardiac infarction
  • Allergic contact dermatitis
  • History of drug/alcohol addiction, habitual smoker

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.5mg Cetylpyridinium Chloride (CPC)
1.5mg CPC will be taken daily for four weeks.
Drug: Cetylpyridinium Chloride (CPC)
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
Experimental: 4.5mg Cetylpyridinium Chloride (CPC)
4.5mg CPC will be taken daily for four weeks.
Drug: Cetylpyridinium Chloride (CPC)
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
Placebo Comparator: Control
Placebo will be taken daily for four weeks
Drug: placebo
Control group takes the placebo for the same period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in procollagen type III N-terminal peptide
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in insulin like growth factor 1 (IGF-1)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in transforming growth factor β1 (TGF-β1)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Myostatin
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in tumor necrosis factor α (TNF-α)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in interleukin 1 (IL-1)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in fatty acid binding protein 3 (FABP3)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in monocyte chemoattractant protein 1 (MCP-1)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Skeletal muscle index
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in short physical performance battery (SPPB)
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
Change from baseline in Grip strength
Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration
baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHRM-CPC2

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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