Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02800759
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C087638', 'term': 'cetyl myristoleate'}, {'id': 'C103009', 'term': 'Reppal PES 100'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CHANGE of Pain', 'timeFrame': 'change from baseline at 3 months', 'description': 'using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)'}], 'secondaryOutcomes': [{'measure': 'difference in NRS pain score from baseline within groups', 'timeFrame': 'at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up'}, {'measure': 'change of the WOMAC score', 'timeFrame': 'change from baseline at 3 months', 'description': 'using the Korean version of WOMAC'}, {'measure': 'Global Impression of Change', 'timeFrame': 'at 3-month follow-up', 'description': 'a scale ranging from 1 (very much improved) to 7 (very much worse).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Knee Pain Intermittent']}, 'referencesModule': {'references': [{'pmid': '23646102', 'type': 'BACKGROUND', 'citation': 'Thiem U, Lamsfuss R, Gunther S, Schumacher J, Baker C, Endres HG, Zacher J, Burmester GR, Pientka L. Prevalence of self-reported pain, joint complaints and knee or hip complaints in adults aged >/= 40 years: a cross-sectional survey in Herne, Germany. PLoS One. 2013 Apr 30;8(4):e60753. doi: 10.1371/journal.pone.0060753. Print 2013.'}, {'pmid': '22147711', 'type': 'BACKGROUND', 'citation': 'Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.'}, {'pmid': '21907813', 'type': 'BACKGROUND', 'citation': 'Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.'}, {'pmid': '15471891', 'type': 'BACKGROUND', 'citation': 'Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P, Leeb B, Lequesne M, Lohmander S, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Swoboda B, Varatojo R, Verbruggen G, Zimmermann-Gorska I, Dougados M; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005 May;64(5):669-81. doi: 10.1136/ard.2004.028886. Epub 2004 Oct 7.'}, {'pmid': '17719803', 'type': 'BACKGROUND', 'citation': 'Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.'}, {'pmid': '18279766', 'type': 'BACKGROUND', 'citation': 'Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.'}, {'pmid': '20170770', 'type': 'BACKGROUND', 'citation': 'Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.'}, {'pmid': '22563589', 'type': 'BACKGROUND', 'citation': 'Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.'}, {'pmid': '24462672', 'type': 'BACKGROUND', 'citation': 'McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC). Nutraceuticals containing CMO are used to improve knee pain despite the lack of placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial is to explore the minimal effective dose of CMO for relieving knee joint pain.', 'detailedDescription': 'Methods: Twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; Groups A, B, C that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of Cis-9-cetylmyristoleate (CMO), and control Group D (starch 100%). The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sub-healthy persons \\>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.\n\nExclusion Criteria:\n\n* current medication use related to arthritis;\n* current use of FAC containing products;\n* clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst;\n* previous history of knee surgery;\n* pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods;\n* major pain other than knee joint pain;\n* current treatment of gastritis or gastric ulcer;\n* abnormal screening laboratory results;\n* major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled;\n* history of major procedures or operations that might affect study results;\n* enrollment in another clinical trial or human application testing; and\n* judged as unsuitable for human application testing.'}, 'identificationModule': {'nctId': 'NCT02800759', 'briefTitle': 'Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University'}, 'officialTitle': 'The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain', 'orgStudyIdInfo': {'id': '1307-098-506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '100% of JOINTRUS®', 'description': 'After randomization, 100% dose of JOINTRUS® is taken per day for 3 months in 7 sub-healthy persons \\>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.', 'interventionNames': ['Dietary Supplement: JOINTRUS®']}, {'type': 'ACTIVE_COMPARATOR', 'label': '80% of JOINTRUS®', 'description': 'After randomization, 80% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons \\>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.', 'interventionNames': ['Dietary Supplement: 80% dose of JOINTRUS®']}, {'type': 'ACTIVE_COMPARATOR', 'label': '62.4% of JOINTRUS®', 'description': 'After randomization, 62.4% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons \\>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.', 'interventionNames': ['Dietary Supplement: 62.4% dose of JOINTRUS®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Starch 100%', 'description': 'After randomization, starch 100% was taken per day for 3 months in 7 sub-healthy persons \\>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.', 'interventionNames': ['Dietary Supplement: Starch 100%']}], 'interventions': [{'name': 'JOINTRUS®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate'], 'description': '100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate', 'armGroupLabels': ['100% of JOINTRUS®']}, {'name': '80% dose of JOINTRUS®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate'], 'description': '80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate', 'armGroupLabels': ['80% of JOINTRUS®']}, {'name': '62.4% dose of JOINTRUS®', 'type': 'DIETARY_SUPPLEMENT', 'description': '62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate', 'armGroupLabels': ['62.4% of JOINTRUS®']}, {'name': 'Starch 100%', 'type': 'DIETARY_SUPPLEMENT', 'description': '0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate', 'armGroupLabels': ['Starch 100%']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Jeeyoun Moon', 'investigatorAffiliation': 'Seoul National University'}}}}