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NCT Number: NCT02297997

Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cetylpyridinium chloride

Drug

Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.

Other names: CEGATON Troche

Placebo

Drug

Control group takes the placebo for the same period.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia: An Exploratory Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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