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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002790
Receipt No. R000003393
Scientific Title Open labeled clinical research on utility of pentosan polysulfate(pentosan) to osteoarthritis of the knee
Date of disclosure of the study information 2009/11/22
Last modified on 2009/11/22

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Basic information
Public title Open labeled clinical research on utility of pentosan polysulfate(pentosan) to osteoarthritis of the knee
Acronym Clinical research on utility of pentosan to knee OA
Scientific Title Open labeled clinical research on utility of pentosan polysulfate(pentosan) to osteoarthritis of the knee
Scientific Title:Acronym Clinical research on utility of pentosan to knee OA
Region
Japan

Condition
Condition almost healthy with mild osteoarthritis of the knee
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pentosan Polysulphate Sodium (pentosan) is used worldwide, either by injection in the muscle or by oral administration, as an OA treatment for dogs and racehorses. From the results of previous in vitro and animal model studies, we have proposed that the spectrum of pharmacological activities exhibited by pentosan would qualify it as DMOADs. The aim of this study is to assess the clinical effectiveness, functional outcome, safety, and patient satisfaction of a series of subcutaneous injections of NaPPS in patients with symptomatic primary OA of the knee.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All patients were prospectively reviewed at entry and at weeks 1, 2, 3, 4, 8, 12, 16, 24, and 52 with a physical examination of the knee and VAS for stiffness, pain at rest or at walking, with ROM exercises, and with walking up and down stairs. The primary outcome variable in the knee pain was measured by VAS at each visit.
Blood and urine were checked including usual biochemical test and coagulation test.
Weight bearing radiographs were reviewed at the baseline and at the end of study to grade the degree of OA.
Key secondary outcomes To check the change of the metabolism in the cartilage, procollagen new synthesis (CPII) and degradation of type II Collagen (C2C) in the blood was measured with an ELISA kit, in accordance with the manufacturer's instructions, and, in addition,WOMAC 3.1 (Likert) was used to measure secondary effectiveness (pain, stiffness, physical function, social function, emotional function).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 As a utilized agents, Pentosanpolysulfat SP 54, used in this study, was manufactured and supplied in sterile injectable vials (pentosan 100mg/ml) by bene-Arzneimittel GmbH, Munich, Germany.
The treatment consisted of 6 weekly subcutaneous injections (subcutaneous injection) of pentosan(2mg/kg), following the two weeks of test injections (the first was 25mg, second was 50mg).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Symptomatic patients with primary OA of the knee affecting the tibio-femoral and/or the patello-femoral compartment were consulted by senior orthopaedic surgeons who discussed their preferred management strategy. The radiographic indications of OA were grades 1 to 2 in Koshino's classification and stages 1 to 3a in the Hokkaido University stage grading system, changing into the Kellgren-Lawrence Grading System for OA, 1957, grades 1 to 2.
Key exclusion criteria 1. Patients who received previous intra-articular corticosteroid or another drug injection in the knee joint within the previous 3 months.
2. Patients who had other lower-extremity musculoskeletal disability or pain.
3. Patients who had pain exceeding 45 mm on a 100-mm visual analogue scale (VAS, 0- 100, 100 as worst pain) immediately following walking for 50 m.
4. Patients who had any bleeding tendency with anti-coagulant drugs (besides aspirin) having gastric or duodenal ulcer or with suspicion of alimentary tract bleeding.
5. Patients who had other severe disease or handicap (for example (i.e.), liver, kidney, and bone marrow).
6. Patients who had a past history of drug allergy.
7. Patients who were pregnant or were breastfeeding.
8. Patients who had difficulty providing us with information.
9. Patients who had difficulty with the informed consent.
About using NSAIDs, the patients were not eliminated if they could have a two-week wash-out period before entering into this study.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shindo, M.D., PhD
Organization Nagasaki University Hospital
Division name Orthopedic Surgery
Zip code
Address 1-7-1, Sakamoto, Nagasaki-city, Nagasaki, 852-8501, Japan
TEL 095-819-7321
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Kumagai, M.D., PhD
Organization Nagasaki University Hospital
Division name Orthopedic Surgery
Zip code
Address 1-7-1, Sakamoto, Nagasaki-city, Nagasaki, 852-8501, Japan
TEL 095-819-7321
Homepage URL
Email kenjikum@nagasaki-u.ac.jp

Sponsor
Institute Pentosan Research Society
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)
Nagasaki University Hospital (Nagasaki Prefecture)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The dose of this pentosan affected the blood coagulation tests, but the value in the study was within a safe range. A tiny abnormal finding was noted in serum chemistry: i.e., serum triglyceride at one hour after injection, but it was reduced quickly in the follow-up period.
The hydroarthroses were reduced quickly in all cases.
The ROM of the knee joint improved significantly. The clinical assessments, i.e., knee flexion, pain at walking, pain just after a climb up and down stairs, pain just after ROM exercise all improved significantly. The concentration of C2C in the blood decreased significantly.
The clinical benefits of this study continued for almost one year.
There was a statistically significant improvement from the baseline score in knee pain as measured by VAS at the 11th, 15th, 24th, and 52nd weeks.
These good results were thought to be due to the improvement of cartilage metabolism, synovium condition and anti-inflammatory function by pentosan.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2007 Year 09 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 22 Day
Last modified on
2009 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003393

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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