UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007719 |
|---|---|
| Receipt number | R000008612 |
| Scientific Title | Clinical study on the analgesic efficacy of a 4-week combination of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch (A randomized, open-label, parallel-group, controlled study compared to home based exercise therapy) |
| Date of disclosure of the study information | 2012/04/11 |
| Last modified on | 2022/10/19 14:19:51 |
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Basic information
Public title
Clinical study on the analgesic efficacy of a 4-week combination of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch (A randomized, open-label, parallel-group, controlled study compared to home based exercise therapy)
Acronym
Clinical study on the analgesic efficacy of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch
Scientific Title
Clinical study on the analgesic efficacy of a 4-week combination of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch (A randomized, open-label, parallel-group, controlled study compared to home based exercise therapy)
Scientific Title:Acronym
Clinical study on the analgesic efficacy of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to perform an exploratory examination of the analgesic efficacy and safety of the combination of NSAIDs patch and celecoxib in patients with Knee Osteoarthritis who responded poorly to monotherapy with NSAIDs patch, in comparison with the combination of NSAIDs patch and home based exercise therapy, which is recommended in the treatment guidelines for osteoarthritis of the knee, in a 4-week randomized, open-label, parallel-group, controlled study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Average change in pain VAS at the final assessment from the baseline.
Key secondary outcomes
(1) General improvement rate evaluated by doctor at final assessment (assessed in five stages: 1. Marked improvement, 2. Moderate improvement, 3. Slight improvement, 4. Unchanged, 5. Worse).
(2) Comparison of improvement rates (changes from baseline) of Japanese Knee Osteoarthritis Measure score at final assessment.
(3) Average change in pain VAS according to patient diary (Comparison between baseline and day 1, day 3, day 7, day 14, and day 28 of celecoxib treatment or exercise treatment).
(4) Health and sleep patterns according to patient diary (Comparison between baseline and day 1, day 3, day 7, day 14, and day 28 of celecoxib treatment or exercise treatment).
(5) Compliance with exercise treatment according to patient questionnaire on treatment at final assessment.
(6) Treatment compliance according to patient questionnaire on treatment at final assessment.
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
A fixed daily dose of Celecoxib (200mg/day in 2 divided doses) will be administered orally for 4 weeks.
Interventions/Control_2
home based exercise therapy for 4 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with osteoarthritis of the knee by the doctor (irrelevant of gender)
(2) Age range from 30 to 90 years.
(3) Patients responding poorly to NSAID patch alone for more than 2 weeks (visit 2) (VAS value ≥ 30 mm).
(4) Patients graded between 1 to 4 according to the Kellgren and Lawrence Classification.
(5) Patients willing to sign written consent regarding participation in this study.
Key exclusion criteria
(1) Patients diagnosed with rheumatoid arthritis, inflammatory arthritis, or gout, or those with injuries at evaluated region.
(2) Patients who have received surgical or drug treatment for the evaluated knee during the study period.
(3) Patients with diseases requiring continuous or intermittent steroid administration.
(4) Patients requiring use of topical drugs (e.g., ointment, suppository) during the study period.
(5) Patients with history of hypersensitivity to the ingredient of celecoxib, sulfonamide, or ketoprofen.
(6) Patients with (history of) aspirin asthma (asthma attacks induced by NSAIDs, analgesics, etc.).
(7) Patients with history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, and octocrylene.
(8) Patients with history of photosensitivity.
(9) Patients with peptic ulcers.
(10) Patients with severe hepatic disorders.
(11) Patients with severe renal disorders.
(12) Patients with severe cardiac dysfunctions.
(13) Perioperative patients undergoing coronary artery bypass reconstruction.
(14) Women at the end of pregnancy.
(15) Other patients considered unsuited for the study by their doctors.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Watanabe |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
291 S1W17, Chuo-ku, Sapporo, 060-8556, Japan
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Watanabe |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
011-611-2111
Homepage URL
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
| 2012 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008612
