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Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

Primary Purpose

Sarcopenia

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
cetylpyridinium chloride
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring sarcopenia, cetylpyridinium chloride

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1.5mg Cetylpyridinium Chloride

    3mg Cetylpyridinium Chloride

    4.5mg Cetylpyridinium Chloride

    6mg Cetylpyridinium Chloride

    Control

    Arm Description

    Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.

    Cetylpyridinium chloride of 3mg will be taken daily for two weeks.

    Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.

    Cetylpyridinium chloride of 6mg will be taken daily for two weeks.

    Placebo will be taken daily for two weeks.

    Outcomes

    Primary Outcome Measures

    Change from baseline in procollagen type III N-terminal peptide
    Change from baseline in myostatin
    Change from baseline in TNF-α
    Change from baseline in IL-6
    Change from baseline in urinary creatinine

    Secondary Outcome Measures

    Change from baseline in CRP
    Change from baseline in Hemoblobin
    Change from baseline in Albumin
    Change from baseline in Vitamin D

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    March 24, 2021
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02297997
    Brief Title
    Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy
    Official Title
    Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 13, 2014 (Actual)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia
    Keywords
    sarcopenia, cetylpyridinium chloride

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1.5mg Cetylpyridinium Chloride
    Arm Type
    Experimental
    Arm Description
    Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
    Arm Title
    3mg Cetylpyridinium Chloride
    Arm Type
    Experimental
    Arm Description
    Cetylpyridinium chloride of 3mg will be taken daily for two weeks.
    Arm Title
    4.5mg Cetylpyridinium Chloride
    Arm Type
    Experimental
    Arm Description
    Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
    Arm Title
    6mg Cetylpyridinium Chloride
    Arm Type
    Experimental
    Arm Description
    Cetylpyridinium chloride of 6mg will be taken daily for two weeks.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo will be taken daily for two weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    cetylpyridinium chloride
    Other Intervention Name(s)
    CEGATON Troche
    Intervention Description
    Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Control group takes the placebo for the same period.
    Primary Outcome Measure Information:
    Title
    Change from baseline in procollagen type III N-terminal peptide
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in myostatin
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in TNF-α
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in IL-6
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in urinary creatinine
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Secondary Outcome Measure Information:
    Title
    Change from baseline in CRP
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in Hemoblobin
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in Albumin
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration
    Title
    Change from baseline in Vitamin D
    Time Frame
    baseline, immediately after dosing end, two weeks after the end of administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sun Gun Chung, MD, PhD
    Organizational Affiliation
    Seoul National University College of Medicine
    Official's Role
    Principal Investigator

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    Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

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