臨床研究等提出・公開システム

Date of registration	June. 02, 2025
Last modified on	July. 16, 2026
Trial ID	jRCT2031250145

Scientific Title	A phase III, parallel assignment, multicenter, randomized controlled trial, placebo control trial to assess the efficacy and safety of NaPPS in people with knee-osteoarthritis
Public Title	A phase III, parallel assignment, multicenter, randomized controlled trial, placebo control trial to assess the efficacy and safety of NaPPS in people with knee-osteoarthritis

Contact for Scientific Queries	Name	Matsumoto Tadashi
	Affiliation	ReqMed Company, Ltd.
	Address	Taiju-Life Bldg. 1-7-23 Morino Machida-City, Tokyo
	Telephone	+81-42-732-2207
	E-mail	matsumoto@reqmed.co.jp
Contact for Public Queries	Name	Kubo Tomotsugu
	Affiliation	ReqMed Company, Ltd.
	Address	Taiju-Life Bldg. 1-7-23 Morino Machida-City, Tokyo
	Telephone	+81-42-732-2207
	E-mail	tomotsugu.kubo@reqmed.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 01, 2025
Target sample size		160
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients diagnosed with knee osteoarthritis according to ACR classification criteria, among whom grade 2 or grade 3 of K-L classification in one knee or both knees are found in the radiological images of the standing front in patients except for secondary knee osteoarthritis. 2) Patients who are able to talk (to explain or indicate their symptoms) 3) Patients aged >=40 years and <75 years at the time of informed consent 4) Japanese patients living in Japan
	Exclusion Criteria	<At the time of provisional registration> 1) Patients with any of the following complications (1) Diseases with hemorrhagic diathesis (gastrointestinal haemorrhages such as gastric ulcer and duodenal ulcer, cerebral hemo (2) Cardiovascular disease associated with a high risk of bleeding (aneurysm, etc.), hematologic disease (thrombocytopenia, etc.) rrhage, etc.) (3) Heparin-induced thrombocytopenia type2 (4) Drug hypersensitivity to heparin or pentosan polysulfate (5) Severe allergic disease (6) Maculopathy (including suspected) (7) Malignant tumor (8) Diseases in which problems arise in patient safety or treatment of complications by prohibiting the administration of prohibited concomitant drugs (9) Other diseases considered by the investigator or sub-investigator to have the potential to affect the efficacy or safety evaluation in this study 2) Patients with any of the following (1) Thrombocytopenia (not applicable if the cause is obvious such as due to drug and temporary, and the investigator (or sub-investigator) judge that there are no safety problem) (2) Heparin-induced thrombocytopenia type2 (3) Drug hypersensitivity to heparin or pentosan polysulfate (4) Severe drug-induced hypersensitivity (5) Malignancy (not applicable if metastatic or recurrent disease has not occurred after complete resection and treatment is not required, and 5 years or more have passed at the tentative enrollment assessment date (Visit1)) (6) Other diseases considered by the investigator or sub-investigator to have the potential to affect the efficacy or safety evaluation in this study 3) Subjects with AST>100 IU/L, ALT>100 IU/L or APTT levels above the upper limit of the reference level of the trial site 4) Patients who have undergone surgery (excluding minimally invasive surgical treatment) within 24 weeks prior to obtaining informed consent or who are scheduled for the study period. 5) Patients who received the drugs or therapies in the other clinical trials within 16 weeks prior to obtaining informed consent 6) Patients who used heparin (excluding heparin analogues) or a polysulfate pentosan preparation within 16 weeks prior to obtaining informed consent 7) Patients who received platelet-rich plasma (PRP) therapy of the knee joint within 24 weeks prior to obtaining informed consent 8) Subjects who have participated in a clinical trial or treatment of regenerative medicine products excluding platelet-rich plasma (PRP) therapy for the knee joint within 1 year prior to obtaining informed consent 9) Subjects who received intra-articular administration of hyaluronic acid to the knee or systemic of corticosteroids or intra-articular administration of corticosteroids within 4 weeks prior to the tentative enrollment assessment date (Visit1) 10) Patients receiving systemic administration of non-steroidal anti-inflammatory drugs or topical administration of topical drugs to the knee (ointment, patch, application, etc.), acetaminophen (excluding use as rescue medication), muscle relaxants, narcotic analgesics, non-narcotic analgesics, other drugs with indications for pain, or chondroitin preparations (excluding ophthalmic preparations) within 7 days prior to the tentative date of registration (Visit1) 11) Patients who used acetaminophen (including use as a rescue medication) within 2 days prior to the tentative enrollment assessment date (Visit1) 12) Patients who used supplements containing hyaluronan, glucosamine, chondroitin, collagen, and proteoglycans within 4 weeks prior to the tentative enrollment assessment date (Visit1) 13) Patients with significant functional impairment due to fracture or injury in the lower extremity of the knee side to be evaluated 14) Patients who weigh more than 100 kg Patients with alcoholism or drug dependence 16) Pregnant women or nursing mothers. Patients of childbearing potential who wish to become pregnant or who do not consent to appropriate contraception during the study period 17) Patients who have received NaPPS investigational products 18) Patients participating in other clinical trials 19) Patients considered by the investigator or sub-investigator who have difficulty completing the survey, or who are not appropriate for the safe conduct of the study. <At the time of registration> 1) Patients whose APTT exceeded the upper limit of the institutional reference value in the APTT study by the registration trial (Visit3) 2) Patients who become pregnant by the registration trial (Visit3) 3) Patients who were found to meet any of the exclusion criteria of provisional registration by the registration trial (Visit3)
	Age Minimum	40age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoarthritis, Knee
Intervention(s)		Patient with knee osteoarthritis is subcutaneously administered NaPPS or placebo once a week for 8 weeks (8 times in total), and the dose is 2 mg/kg of body weight. Patient should be administered to the left or right upper arm, left or right thigh, or left or right abdomen, and should be administered to a different site than the previous dose.
Health Condition(s) Code		D020370
Primary Outcome(s)		WOMAC-A (mean points on the sections): pain in 48 hours (the evaluated knee) The primary endpoint is the amount of change (reduction) of WOMAC-A score from the baseline (Visit3) to the 8-week study treatment (Visit11) in the knees evaluated.
Secondary Outcome(s)		Percentage improved based on OMERACT-OARSI Responder Criteria

Primary Sponsor	ReqMed Company, Ltd.

Name of Certified Review Board	Machida Municipal Hospital Institutional Review Board
Address	2-15-14, Asahimachi, Machida-shi , Tokyo
Telephone	+81-42-710-5677
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	HURECS Review Board of Human Rights and Ethics for Clinical Studies
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-5213-0028
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Sanin Rosai Hospital Institutional Review Board
Address	1-8-1, Kaikeshinden, Yonago-shi, Tokyo
Telephone	+81-859-33-8181
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Central Institutional Review Board
Address	1-4-28 Mita, Minato-ku, Tokyo
Telephone	+81-3-3454-3311
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Sagamihara National Hospital Institutional Review Board
Address	18-1, Sakuradai, Minami-ku sagamihara-shi, Tokyo
Telephone	+81-42-742-8311
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Showa Medical University Institutional Review Board
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Telephone	+81-3-3784-8000
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Chibaken Saiseikai Narashino Hospital Institutional Review Board
Address	1-1-1, Izumicho, Narashino-shi, Tokyo
Telephone	+81-47-473-1281
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Yokohama Rosai Hospital Institutional Review Board
Address	3211, Kozukuecho, Yokohama-shi Kohoku-ku, Tokyo
Telephone	+81-45-474-8111
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Polaris Institutional Review Board
Address	4-16, Honcho, Kawaguchi-shi, Tokyo
Telephone	+81-48-222-5015
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Japanese Red Cross Fukuoka Hospital Institutional Review Board
Address	3-1-1, Ogusu, Fukuoka-shi Minami-ku, Tokyo
Telephone	+81-570-03-1211
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Hamanomachi Hospital Institutional Review Board
Address	3-3-1, Nagahama, Fukuoka-shi Chuo-ku, Tokyo
Telephone	+81-92-721-0831
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Tokyo Metropolitan Bokutoh Hospital Institutional Review Board
Address	4-23-15, Kotobashi, Sumida-ku, Tokyo
Telephone	+81-3-3633-6151
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-3813-3111
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Fujisawa City Hospital Institutional Review Board
Address	2-6-1, Fujisawa, Fujisawa-shi, Tokyo
Telephone	+81-466-25-3111
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	SHOWA Medical University Koto Toyosu Hospital Institutional Review Board
Address	5-1-38, Toyosu, Koto-ku, Tokyo
Telephone	+81-3-6204-6000
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Nihonbashi Sakura Clinic Institutional Review Board
Address	1-9-2, Nihonbashi-kayabacho, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-6661-9061
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Fukuoka University Hospital Institutional Review Board
Address	2-2-20, Tenjin, Fukuoka-shi Chuo-ku, Tokyo
Telephone	+81-92-801-1011
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Tokyo Central Institutional Review Board
Address	5-11-8, Nishinippori, Arakawa-ku, Tokyo
Telephone	+81-3-3805-8181
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Teikyo University Hospital, Mizonokuchi Institutional Review Board
Address	5-1-1, Futago, Kawasaki-shi Takatsu-ku, Tokyo
Telephone	+81-44-844-3333
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	HURECS Review Board of Human Rights and Ethics for Clinical Studies
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-5213-0028
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Nihonbashi Sakura Clinic Institutional Review Board
Address	1-9-2, Nihonbashi-kayabacho, Chuo-ku, Tokyo
Telephone	+81-3-6661-9061
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Chutoen General Medical Center Institutional Review Board
Address	1-1, Shobugaike, Kakegawa-shi, Tokyo
Telephone	+81-537-21-5555
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	SHOWA Medical University Koto Toyosu Hospital Institutional Review Board
Address	5-1-38, Toyosu, Koto-ku, Tokyo
Telephone	+81-3-6204-6000
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Nagasaki University Hospital Institutional Review Board
Address	1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, Tokyo
Telephone	+81-95-819-7256
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	Nihonbashi Sakura Clinic Institutional Review Board
Address	1-9-2, Nihonbashi-kayabacho, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-6661-9061
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	National Hospital Organization Saitama Hospital Institutional Review Board
Address	2-1, Suwa, Wako-shi, Tokyo
Telephone	+81-48-462-1101
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	National Hospital Organization Toyohashi Medical Center Institutional Review Board
Address	50, Hamamichigami, Imure-cho, Toyohashi-shi, Tokyo
Telephone	+81-532-62-0301
Approval Status	Approval
Date of approval	Feb. 25, 2025

Name of Certified Review Board	National Hospital Organization Chiba Medical Center Institutional Review Board
Address	4-1-2, Tsubakimori, Chuo-ku Chiba-shi, Tokyo
Telephone	+81-43-251-5348
Approval Status	Approval
Date of approval	Feb. 25, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 16, 2026	(this page)	Changes
2	Dec. 04, 2025	Detail	Changes
1	June. 02, 2025	Detail

List of change history