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CPC2: Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02575235
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
9
Actual Duration (Months)
11.1
Patients Per Site Per Month

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 pre-sarcopenia or sarcopenia over the age of 60

Condition or Disease Intervention/Treatment Phase
  • Drug: Cetylpyridinium Chloride (CPC)
  • Drug: placebo
 Early Phase 1

Detailed Description

75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four 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, four 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 :
100 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
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1.5mg Cetylpyridinium Chloride (CPC)

1.5mg CPC will be taken daily for four weeks.

Drug: Cetylpyridinium Chloride (CPC)
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
Experimental: 4.5mg Cetylpyridinium Chloride (CPC)

4.5mg CPC will be taken daily for four weeks.

Drug: Cetylpyridinium Chloride (CPC)
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
Placebo Comparator: Control

Placebo will be taken daily for four 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, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

Secondary Outcome Measures

  1. Change from baseline in insulin like growth factor 1 (IGF-1) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  2. Change from baseline in transforming growth factor β1 (TGF-β1) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

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

  4. Change from baseline in tumor necrosis factor α (TNF-α) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  5. Change from baseline in interleukin 1 (IL-1) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  6. Change from baseline in fatty acid binding protein 3 (FABP3) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  7. Change from baseline in monocyte chemoattractant protein 1 (MCP-1) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  8. Change from baseline in Skeletal muscle index [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  9. Change from baseline in short physical performance battery (SPPB) [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration]

  10. Change from baseline in Grip strength [baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four 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:
  • Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M < 7.0kg/m2, F < 5.7kg/m2
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

Site City State Country Postal Code
1 Seoul National University College of Medicine Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02575235
Other Study ID Numbers:
  • SNUHRM-CPC2
First Posted:
Oct 14, 2015
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 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 Oct 8, 2021