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Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02297997
Collaborator
(none)
65
Enrollment
5
Arms
11.6
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: cetylpyridinium chloride
  • Drug: Placebo
 Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study
Actual Study Start Date :
Nov 13, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in procollagen type III N-terminal peptide [baseline, immediately after dosing end, two weeks after the end of administration]

    2. Change from baseline in myostatin [baseline, immediately after dosing end, two weeks after the end of administration]

    3. Change from baseline in TNF-α [baseline, immediately after dosing end, two weeks after the end of administration]

    4. Change from baseline in IL-6 [baseline, immediately after dosing end, two weeks after the end of administration]

    5. Change from baseline in urinary creatinine [baseline, immediately after dosing end, two weeks after the end of administration]

    Secondary Outcome Measures

    1. Change from baseline in CRP [baseline, immediately after dosing end, two weeks after the end of administration]

    2. Change from baseline in Hemoblobin [baseline, immediately after dosing end, two weeks after the end of administration]

    3. Change from baseline in Albumin [baseline, immediately after dosing end, two weeks after the end of administration]

    4. Change from baseline in Vitamin D [baseline, immediately after dosing end, two weeks after the end of administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M < 7.0kg/m2, F < 5.7kg/m2
    1. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Sun Gun Chung, MD, PhD, Seoul National University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sun Gun Chung, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02297997
    Other Study ID Numbers:
    • SNUHRM
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Sun Gun Chung, Professor, Seoul National University Hospital
    sarcopenia
    cetylpyridinium chloride
    Additional relevant MeSH terms:
    Sarcopenia
    Cetylpyridinium

    Study Results

    No Results Posted as of Mar 29, 2021