Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

NCT02297997 | Completed Early Phase 1

• 1 other identifier: SNUHRM
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia

Keywords

sarcopenia; cetylpyridinium chloride

Outcome Measures

Primary Outcomes (5)

• Change from baseline in procollagen type III N-terminal peptide

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

• Change from baseline in myostatin

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

• Change from baseline in TNF-α

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

• Change from baseline in IL-6

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

• Change from baseline in urinary creatinine

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

Secondary Outcomes (4)

• Change from baseline in CRP

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

• Change from baseline in Hemoblobin

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

• Change from baseline in Albumin

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

• Change from baseline in Vitamin D

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

Study Arms (5)

1.5mg Cetylpyridinium Chloride

EXPERIMENTAL

Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks.

Drug: cetylpyridinium chloride

3mg Cetylpyridinium Chloride

EXPERIMENTAL

Cetylpyridinium chloride of 3mg will be taken daily for two weeks.

Drug: cetylpyridinium chloride

4.5mg Cetylpyridinium Chloride

EXPERIMENTAL

Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks.

Drug: cetylpyridinium chloride

6mg Cetylpyridinium Chloride

EXPERIMENTAL

Cetylpyridinium chloride of 6mg will be taken daily for two weeks.

Drug: cetylpyridinium chloride

Control

PLACEBO COMPARATOR

Placebo will be taken daily for two weeks.

Drug: Placebo

Interventions

cetylpyridinium chloride DRUG

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

Also known as: CEGATON Troche

1.5mg Cetylpyridinium Chloride; 3mg Cetylpyridinium Chloride; 4.5mg Cetylpyridinium Chloride; 6mg Cetylpyridinium Chloride

Placebo DRUG

Control group takes the placebo for the same period.

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (33)

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MeSH Terms

Conditions

Sarcopenia

Interventions

Cetylpyridinium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sun Gun Chung, MD, PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: November 13, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 29, 2021

Record last verified: 2021-03