Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

March 24, 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: An Exploratory Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

65 people that meet the inclusion criteria on screening test are assigned to one of five groups by randomization. They take the medication for two weeks under double-blind. Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two 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 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)

65

Phase

  • Early Phase 1

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:

  • Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M < 7.0kg/m2, F < 5.7kg/m2 B. Normal grip strength M ≥ 26kg, F ≥ 18kg C. Normal physical performance Gait speed > 0.8m/s
  • Community dwelling

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
Drug: cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Other Names:
  • CEGATON Troche
EXPERIMENTAL: 3mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 3mg will be taken daily for two weeks.
Drug: cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Other Names:
  • CEGATON Troche
EXPERIMENTAL: 4.5mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
Drug: cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Other Names:
  • CEGATON Troche
EXPERIMENTAL: 6mg Cetylpyridinium Chloride
Cetylpyridinium chloride of 6mg will be taken daily for two weeks.
Drug: cetylpyridinium chloride
Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
Other Names:
  • CEGATON Troche
PLACEBO_COMPARATOR: Control
Placebo will be taken daily for two 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, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in myostatin
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in TNF-α
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in IL-6
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in urinary creatinine
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in CRP
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in Hemoblobin
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in Albumin
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two weeks after the end of administration
Change from baseline in Vitamin D
Time Frame: baseline, immediately after dosing end, two weeks after the end of administration
baseline, immediately after dosing end, two 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)

November 13, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (ESTIMATE)

November 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHRM

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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