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

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ClinicalTrials.gov Identifier: NCT02575235
Recruitment Status : Unknown
Verified October 2015 by Sun Gun Chung, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2015
Last Update Posted : October 14, 2015
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 pre-sarcopenia or sarcopenia over the age of 60

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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
Study Start Date : October 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1.5mg Cetylpyridinium Chloride
1.5mg CPC will be taken daily for four weeks.
Drug: CPC
Two study groups take cetylpyridinium chloride of 1.5mg and 4.5mg daily for four weeks.

Experimental: 4.5mg Cetylpyridinium Chloride
4.5mg CPC will be taken daily for four weeks.
Drug: CPC
Two study groups take cetylpyridinium chloride 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.




Primary Outcome Measures :
  1. Change from baseline in procollagen type III N-terminal peptide [ Time Frame: 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 IGF-1 [ Time Frame: 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 TGF-β1 [ Time Frame: 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 [ Time Frame: 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 TNF-α [ Time Frame: 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 IL-1 [ Time Frame: 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 FABP3 [ Time Frame: 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 MCP-1 [ Time Frame: 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 [ Time Frame: 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 SPPB [ Time Frame: 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 [ Time Frame: baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration ]


Information from the National Library of Medicine

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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:

  • Pre-sarcopenia A. Reduced skeletal muscle mass (ASM/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

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): NCT02575235


Contacts
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Contact: Sun Gun Chung, PhD suncg@gmail.com

Locations
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Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Publications:

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Responsible Party: Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02575235    
Other Study ID Numbers: SNUHRM-CPC2
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
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