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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000283 |
Receipt No. | R000000360 |
Scientific Title | Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial. |
Date of disclosure of the study information | 2005/11/15 |
Last modified on | 2017/04/24 |
Basic information | ||
Public title | Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial. | |
Acronym | Effect of NSAID external patch for Knee Osteoarthritis | |
Scientific Title | Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial. | |
Scientific Title:Acronym | Effect of NSAID external patch for Knee Osteoarthritis | |
Region |
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Condition | ||
Condition | Knee Osteoarthritis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effect of non-steroidal anti-inflammatory drugs (NSAIDs) external patch for knee osteoarthritis. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Functional assessment including ADL: JKOM
Assessment of utility and safety. |
Key secondary outcomes | Assessment of pain: VAS.
Assessment of adverse event in the trial period. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Patch group: external patch
NSAIDs external patch were used on the tender spot around the knee joint 2 times (at morning, after bath or at night) per day. The external patch was kept at room temperature. The patients were able to stop their drugs when they no longer required treatment. NSAIDs were limited only one of the following three to prescribe; flurbiprofen, indometacin, and ketoprofen. |
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Interventions/Control_2 | Oral agent group: Oral NSAIDs
NSAIDs were limited only one of the following three to prescribe. These were the top three used in Japan at the present; loxoprofen sodium, diclofenac sodium, and zaltoprofen. They were also required to record exactly how many they had been taking medicine in a note. |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The patient satisfying the following conditions (1)-(6) is included.
(1) Outpatients with knee pain, age 50-80 years old. Both men and women are able to enter the trial. (2) New patients for medical institution concerned, who receiving no treatment for their knees within 1 month before. (3) Patients with the following knee symptoms in the more symptomatic side. Morning stiffness less than 30 minutes, Joint crepitus, Tenderness at the joint space, and palpable osteophytes (4) As comobidity, hypertension, diabetes, and hyperlipidemia under medication are allowed to enter the trial. (5) Patient who agreed to the following examinations. [X-rays]: the anteroposterior view of both knee joints in a standing position were taken and used to confirm the diagnosis. [Laboratory tests]: blood cell count (red blood cell, white blood cell, hemoglobin, hematocrit), biochemical examination (AST, ALT, ALP, BUN, creatinin, total cholesterol, triglyceride, uric acid), and routine urinalysis. (6) Patient who understand aim and contents the trial and cooperate with filling the questionnaire. |
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Key exclusion criteria | (1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day of agreement to enter the trial.
(2) Patients who had done or planned operation against the knee within 6 months before or after the day of agreement to enter the trial. (3) Patients who require intraarticular injection. (4) Patients who require aspiration of joint fluid. (5) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs. (6) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis. (7) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases. (8) Patients who had some difficulty to fill up their treatment diary. (9) Patients with cardiac dysfunction. (10) Patients with liver dysfunction. (11) Patients with renal dysfunction. (12) Patients with peptic ulcer. (13)Patients who had a history of bronchial asthma (Aspirin asthma, etc). (14) Patients who had a history of Anaphylaxis for NSAIDs. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Chief Director, The Japanese Society for Musculoskeletal Rehabilitation | ||||||
Division name | The Japanese Society for Musculoskeletal Rehabilitation, c/o Department of Orthopaedic Surgery, Jichi Medical School | ||||||
Zip code | |||||||
Address | Yakusiji 3311-1, Minami-Kawachimachi, Tochigi | ||||||
TEL | 0285-58-7374 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National Rehabilitation Center for Persons with Disabilities | ||||||
Division name | Director,Training Center | ||||||
Zip code | |||||||
Address | Namiki 4-1, Tokorozawa, Saitama | ||||||
TEL | 04-2995-3100(2010) | ||||||
Homepage URL | |||||||
iwaya@rehab.go.jp |
Sponsor | |
Institute | The Japanese Society for Musculoskeletal Rehabilitation |
Institute | |
Department |
Funding Source | |
Organization | External Pharmaceutical Association |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Japanese Clinical Orthopaedic Association |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Local application of a plaster with non- steroidal anti-inflammatory drugs (NSAIDs) leads to the same level of improvement for knee osteoarthritis in Japanese as oral NSAIDs.
Doi T, Akai M, Fujino K, et al.: Effect of non-steroidal anti-inflammatory drug plasters for knee osteoarthritis in Japanese: A randomized controlled trial. Modern Rheumatology 20(1): 24-33, 2010 |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000360 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |