UMIN-CTR Clinical Trial

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 &#8805; 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
Email

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
Email

Sponsor
Institute	Sapporo Medical University School of Medicine
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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008612