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SarcopeniaEarly Phase 1NCT02297997

Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

A Early Phase 1 study testing cetylpyridinium chloride in people with Sarcopenia, run by Seoul National University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Sarcopenia
What is being tested?
cetylpyridinium chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
No sites listed yet
Study dates
13 Nov 2014to Nov 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Conditions
Sarcopenia
Being tested
cetylpyridinium chloride, Placebo
Keywords
sarcopenia, cetylpyridinium chloride
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetylpyridinium chlorideDrug

    Also called CEGATON Troche

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

  • PlaceboDrug

    Control group takes the placebo for the same period.

Study groups in NCT02297997
Study groupRoleWhat they receive
1.5mg Cetylpyridinium ChlorideExperimentalCetylpyridinium chloride of 1.5mg will be taken daily for two weeks.
Receives: Drug: cetylpyridinium chloride
3mg Cetylpyridinium ChlorideExperimentalCetylpyridinium chloride of 3mg will be taken daily for two weeks.
Receives: Drug: cetylpyridinium chloride
4.5mg Cetylpyridinium ChlorideExperimentalCetylpyridinium chloride of 4.5mg will be taken daily for two weeks.
Receives: Drug: cetylpyridinium chloride
6mg Cetylpyridinium ChlorideExperimentalCetylpyridinium chloride of 6mg will be taken daily for two weeks.
Receives: Drug: cetylpyridinium chloride
ControlPlacebo comparatorPlacebo will be taken daily for two weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in procollagen type III N-terminal peptide

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  2. Change from baseline in myostatin

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  3. Change from baseline in TNF-α

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  4. Change from baseline in IL-6

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  5. Change from baseline in urinary creatinine

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

Secondary outcomes (4)

  1. Change from baseline in CRP

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  2. Change from baseline in Hemoblobin

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  3. Change from baseline in Albumin

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

  4. Change from baseline in Vitamin D

    Measured: baseline, immediately after dosing end, two weeks after the end of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study start13 Nov 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297997
Sponsor's protocol ID
SNUHRM
Status last verified
Mar 2021
First submitted
19 Nov 2014
Last updated
29 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9.

    PubMed 19657557

  • Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.

    PubMed 12028177

  • Hong S, Oh HJ, Choi H, Kim JG, Lim SK, Kim EK, Pyo EY, Oh K, Kim YT, Wilson K, Choi WH. Characteristics of body fat, body fat percentage and other body composition for Koreans from KNHANES IV. J Korean Med Sci. 2011 Dec;26(12):1599-605. doi: 10.3346/jkms.2011.26.12.1599. Epub 2011 Nov 29.

    PubMed 22147997

  • Kalyani RR, Corriere M, Ferrucci L. Age-related and disease-related muscle loss: the effect of diabetes, obesity, and other diseases. Lancet Diabetes Endocrinol. 2014 Oct;2(10):819-29. doi: 10.1016/S2213-8587(14)70034-8. Epub 2014 Mar 6.

    PubMed 24731660

  • Ormsbee MJ, Prado CM, Ilich JZ, Purcell S, Siervo M, Folsom A, Panton L. Osteosarcopenic obesity: the role of bone, muscle, and fat on health. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):183-92. doi: 10.1007/s13539-014-0146-x. Epub 2014 Apr 17.

    PubMed 24740742

  • Moller N, Vendelbo MH, Kampmann U, Christensen B, Madsen M, Norrelund H, Jorgensen JO. Growth hormone and protein metabolism. Clin Nutr. 2009 Dec;28(6):597-603. doi: 10.1016/j.clnu.2009.08.015. Epub 2009 Sep 20.

    PubMed 19773097

  • Miller MD, Crotty M, Giles LC, Bannerman E, Whitehead C, Cobiac L, Daniels LA, Andrews G. Corrected arm muscle area: an independent predictor of long-term mortality in community-dwelling older adults? J Am Geriatr Soc. 2002 Jul;50(7):1272-7. doi: 10.1046/j.1532-5415.2002.50316.x.

    PubMed 12133024

  • Enoki H, Kuzuya M, Masuda Y, Hirakawa Y, Iwata M, Hasegawa J, Izawa S, Iguchi A. Anthropometric measurements of mid-upper arm as a mortality predictor for community-dwelling Japanese elderly: the Nagoya Longitudinal Study of Frail Elderly (NLS-FE). Clin Nutr. 2007 Oct;26(5):597-604. doi: 10.1016/j.clnu.2007.06.008. Epub 2007 Jul 31.

    PubMed 17669559

  • Stephen WC, Janssen I. Sarcopenic-obesity and cardiovascular disease risk in the elderly. J Nutr Health Aging. 2009 May;13(5):460-6. doi: 10.1007/s12603-009-0084-z.

    PubMed 19390754

  • Rolland Y, Czerwinski S, Abellan Van Kan G, Morley JE, Cesari M, Onder G, Woo J, Baumgartner R, Pillard F, Boirie Y, Chumlea WM, Vellas B. Sarcopenia: its assessment, etiology, pathogenesis, consequences and future perspectives. J Nutr Health Aging. 2008 Aug-Sep;12(7):433-50. doi: 10.1007/BF02982704.

    PubMed 18615225

  • Landi F, Marzetti E, Martone AM, Bernabei R, Onder G. Exercise as a remedy for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):25-31. doi: 10.1097/MCO.0000000000000018.

    PubMed 24310054

  • Adamo ML, Farrar RP. Resistance training, and IGF involvement in the maintenance of muscle mass during the aging process. Ageing Res Rev. 2006 Aug;5(3):310-31. doi: 10.1016/j.arr.2006.05.001. Epub 2006 Sep 1.

    PubMed 16949353

  • Morley JE, Malmstrom TK. Frailty, sarcopenia, and hormones. Endocrinol Metab Clin North Am. 2013 Jun;42(2):391-405. doi: 10.1016/j.ecl.2013.02.006.

    PubMed 23702408

  • Dalton JT, Barnette KG, Bohl CE, Hancock ML, Rodriguez D, Dodson ST, Morton RA, Steiner MS. The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial. J Cachexia Sarcopenia Muscle. 2011 Sep;2(3):153-161. doi: 10.1007/s13539-011-0034-6. Epub 2011 Aug 2.

    PubMed 22031847

  • White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K, Wei JY, Hoffman AR, Salvatori R, Ettinger MP, Morey MC, Blackman MR, Merriam GR; Capromorelin Study Group. Effects of an oral growth hormone secretagogue in older adults. J Clin Endocrinol Metab. 2009 Apr;94(4):1198-206. doi: 10.1210/jc.2008-0632. Epub 2009 Jan 27.

    PubMed 19174493

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing cetylpyridinium chloride in people with Sarcopenia, run by Seoul National University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in procollagen type III N-terminal peptide (time frame: baseline, immediately after dosing end, two weeks after the end of administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297997, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.

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