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Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

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ClinicalTrials.gov Identifier: NCT02297997
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital

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
Sarcopenia 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.

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Study Type : Interventional  (Clinical Trial)
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 : November 13, 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: CEGATON Troche

Placebo Comparator: Control
Placebo will be taken daily for two weeks.
Drug: Placebo
Control group takes the placebo for the same period.




Primary Outcome Measures :
  1. Change from baseline in procollagen type III N-terminal peptide [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  2. Change from baseline in myostatin [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  3. Change from baseline in TNF-α [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  4. Change from baseline in IL-6 [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  5. Change from baseline in urinary creatinine [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]

Secondary Outcome Measures :
  1. Change from baseline in CRP [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  2. Change from baseline in Hemoblobin [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  3. Change from baseline in Albumin [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]
  4. Change from baseline in Vitamin D [ Time Frame: baseline, immediately after dosing end, two weeks after the end of administration ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297997


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Sun Gun Chung, MD, PhD Seoul National University College of Medicine
Publications:

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Responsible Party: Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02297997    
Other Study ID Numbers: SNUHRM
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Keywords provided by Sun Gun Chung, Seoul National University Hospital:
sarcopenia
cetylpyridinium chloride
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents