OsteoarthritisNCT04718649
Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial
A study testing Celebrex with Joins or not in people with Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to improve the joint pain and prevent further damage to the joint. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Celebrex with Joins or not
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 50
- Patients undergoing outpatient treatment in orthopedic surgery for osteoarthritis of the knee joint
- Patients diagnosed with Kellgren-Lawrence grade II or III osteoarthritis of the knee by imaging examination
- Patients with a pain VAS scale of 4 or more out of 10 with a pain in the knee joint during daily activities on flat ground
- Patients confirmed by the examiner for no abnormal results in blood tests, etc.
- Patients who are willing or able to follow doctor's instructions, including joint exercises
- Patients not participating in other clinical trials
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Who cannot join
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to Celebrex or Joins
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
- Patients who underwent total knee arthroplasty within 180 days of the knee joint opposite the pain area
Show all 17Show fewer
- If there is construction or deformation of the knee joint in the pain area
- Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
- Hemoglobin A1c level >8% of patients not managed by diabetes
- Patients with high blood pressure with poor blood pressure control (Systolic Blood Pressure of> 150 mmHg or Diastolic Blood Pressure> 95 mmHg)
- Patients taking PPI drugs for recurrent upper gastrointestinal ulcer or inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
- Patients with abnormal liver function (ALT)> 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine> 2.0 times ULN)
- Patients who took excessive narcotic analgesics for pain in the affected area before the clinical trial
- Patients scheduled for surgery during the clinical trial period
- Patients who received intraarticular injection treatment into the painful area of the knee within 3 months prior to the first visit
- Patients who received systemic steroid treatment within 3 months prior to their first visit
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
the Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul
Yong Gyu Sung, MD, 82-10-9216-0997, ygsung@catholic.ac.kr
Mansoo Kim, MD, PhD, 82-10-7233-3875, kms3779@naver.com
About this study
Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to improve the joint pain and prevent further damage to the joint. Selective Cox-2 inhibitors are the most commonly used nonsteroid anti-inflammatory drugs(NSAIDs) for the treatment of osteoarthritis of the knee joint. However, the safety of selective Cox-2 inhibitors is still controversial. Although these NSAIDs are effective in reducing pain and inflammation, they cannot be called a fundamental treatment for knee arthritis. Accordingly, interest in SYSADOA (Symptomatic Slow-acting Drugs for Osteoarthritis) is gradually increasing.
Joins is a herbal anti-arthritic drug that has various physiological activities and a new concept of osteoarthritis treatment. It has anti-inflammatory, analgesic and joint cartilage protection effects as well as fundamental treatment. Joins is used to improve articular cartilage metabolism, can delay the progression of degenerative arthritis in the knee and compensate for the disadvantages of Selective Cox-2 inhibitors. However, when the selective Cox-2 inhibitor and Joins tablet are used alone, the therapeutic effect on knee degenerative arthritis may be limited. The purpose of this study is to investigate the therapeutic effect and safety of joining together with celecoxib for degenerative arthritis of the knee joint, and to determine the degree of analgesic and anti-inflammatory effects of the combination therapy.
Read the detailed description
The Investigators will conduct research to patients with outpatient treatment for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique that is generally applied to patients with osteoarthritis of the knee joint.
The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study. Such a study plan will be fully explained to the patient in the process of seeking consent for the study before discharge, as it is recorded in detail in the subject description, and only patients who have obtained consent for this will be the subject of the study.
Subjects assigned through randomization are prescribed and taken through the clinical pharmacy. Considering that Joins tab is a sustained-acting drug, the study is divided into Celebrex + Joins placebo group and Celebrex + Joins tab group for up to 12 weeks, and only Joins placeb and Joins are taken for weeks 12th week to 36th week except for celebrex. The total period of the study should be 36 weeks. In the case of the rescue drug, 650mg of Tylenol sustained-release tablet (acetaminophen) in both groups can be taken up to 3 tablets per day, and up to 36 weeks of taking the test drug. Patients should follow the approved usage and dosage, and taking relief drug is prohibited within 1 day before the regular visit. Relief drugs will be prescribed at baseline and from subsequent visits, if necessary, according to the judgment of the investigator.
At the first visit, at 4 weeks, 12 weeks, 24 weeks, 36 weeks, the degree of pain will be measured using the VAS pain scale, and additional pain scale using the WOMAC pain scale, Brief pain inventory (BPI), and SF-36 score.
Knee X-rays will be taken at each outpatient visit as the knee degenerative osteoarthritis patients are measured to check joint space width (JSW) and Kellgren-Lawrence grade to objectively evaluate the effectiveness and stability of the medication effect.
- Conditions
- Osteoarthritis
- Being tested
- Celebrex with Joins or not
- Keywords
- Osteoarthritis, Celebrex, Joins
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex with Joins or notDrug
The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study
| Study group | Role | What they receive |
|---|---|---|
| Celebrex + Joins | Experimental | The experimental group will receive 12 weeks of Celebrex 200mg tab (taken once a day) and Joins (taken 3 times a day) at the clinical pharmacy at the first visit, and will be prescribed only Joins (taken 3 times a day) at week 12. They will only take Joins for another 24 weeks until the 36th week.
The subject's oral medication is received at the clinical pharmacy twice at the time of first visit and at week 12. The follow-up period of the study will be 36 weeks. Receives: Drug: Celebrex with Joins or not |
| Celebrex + Placebo | Placebo comparator | The control group will receive 12 weeks of Celebrex 200mg tab (taken once a day) and placebo (taken 3 times a day) at the clinical pharmacy at the first visit, and will be prescribed only placebo (taken 3 times a day) at week 12. They will only take Joins placebo for another 24 weeks until the 36th week.
The subject's oral medication is received at the clinical pharmacy twice at the time of first visit and at week 12. The follow-up period of the study will be 36 weeks. Receives: Drug: Celebrex with Joins or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale
Measured: changes of the WOMAC score from the first day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Secondary outcomes (6)
Pain Visual Analogue Scale (VAS)
Measured: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Brief pain inventory (BPI)
Measured: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
SF-36 score
Measured: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Serum Biomarker
CTX-1, CTX-2. COMP, HA, NTX-1
Measured: First day of enrollment, 12th week after enrollment, 36th week after enrollment
X-ray
joint space width, Kellgren-Lawrence grade
Measured: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Adverse event
Measured: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718649
- Sponsor's protocol ID
- KC20MISV0634
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04718649
- Acronym / sponsor ID
- KC20MISV0634
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Celebrex, Joins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to improve the joint pain and prevent further damage to the joint. Selective Cox-2 inhibitors are the most commonly used nonsteroid anti-inflammatory drugs(NSAIDs) for the treatment of osteoarthritis of the knee joint. However, the safety of selective Cox-2 inhibitors is still controversial. Although these NSAIDs are effective in reducing pain and inflammation, they cannot be called a fundamental treatment for knee arthritis. Accordingly, interest in SYSADOA (Symptomatic Slow-acting Drugs for Osteoarthritis) is gradually increasing.
Joins is a herbal anti-arthritic drug that has various physiological activities and a new concept of osteoarthritis treatment. It has anti-inflammatory, analgesic and joint cartilage protection effects as well as fundamental treatment. Joins is used to improve articular cartilage metabolism, can delay the progression of degenerative arthritis in the knee and compensate for the disadvantages of Selective Cox-2 inhibitors. However, when the selective Cox-2 inhibitor and Joins tablet are used alone, the therapeutic effect on knee degenerative arthritis may be limited. The purpose of this study is to investigate the therapeutic effect and safety of joining together with celecoxib for degenerative arthritis of the knee joint, and to determine the degree of analgesic and anti-inflammatory effects of the combination therapy.
Detailed description
The Investigators will conduct research to patients with outpatient treatment for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique that is generally applied to patients with osteoarthritis of the knee joint.
The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study. Such a study plan will be fully explained to the patient in the process of seeking consent for the study before discharge, as it is recorded in detail in the subject description, and only patients who have obtained consent for this will be the subject of the study.
Subjects assigned through randomization are prescribed and taken through the clinical pharmacy. Considering that Joins tab is a sustained-acting drug, the study is divided into Celebrex + Joins placebo group and Celebrex + Joins tab group for up to 12 weeks, and only Joins placeb and Joins are taken for weeks 12th week to 36th week except for celebrex. The total period of the study should be 36 weeks. In the case of the rescue drug, 650mg of Tylenol sustained-release tablet (acetaminophen) in both groups can be taken up to 3 tablets per day, and up to 36 weeks of taking the test drug. Patients should follow the approved usage and dosage, and taking relief drug is prohibited within 1 day before the regular visit. Relief drugs will be prescribed at baseline and from subsequent visits, if necessary, according to the judgment of the investigator.
At the first visit, at 4 weeks, 12 weeks, 24 weeks, 36 weeks, the degree of pain will be measured using the VAS pain scale, and additional pain scale using the WOMAC pain scale, Brief pain inventory (BPI), and SF-36 score.
Knee X-rays will be taken at each outpatient visit as the knee degenerative osteoarthritis patients are measured to check joint space width (JSW) and Kellgren-Lawrence grade to objectively evaluate the effectiveness and stability of the medication effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celebrex + Joins | Experimental | Drug: Celebrex with Joins or notThe experimental group will receive 12 weeks of Celebrex 200mg tab (taken once a day) and Joins (taken 3 times a day) at the clinical pharmacy at the first visit, and will be prescribed only Joins (taken 3 times a day) at week 12. They will only take Joins for another 24 weeks until the 36th week. The subject's oral medication is received at the clinical pharmacy twice at the time of first visit and at week 12. The follow-up period of the study will be 36 weeks. |
| Celebrex + Placebo | Placebo comparator | Drug: Celebrex with Joins or notThe control group will receive 12 weeks of Celebrex 200mg tab (taken once a day) and placebo (taken 3 times a day) at the clinical pharmacy at the first visit, and will be prescribed only placebo (taken 3 times a day) at week 12. They will only take Joins placebo for another 24 weeks until the 36th week. The subject's oral medication is received at the clinical pharmacy twice at the time of first visit and at week 12. The follow-up period of the study will be 36 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults over 50
- Patients undergoing outpatient treatment in orthopedic surgery for osteoarthritis of the knee joint
- Patients diagnosed with Kellgren-Lawrence grade II or III osteoarthritis of the knee by imaging examination
- Patients with a pain VAS scale of 4 or more out of 10 with a pain in the knee joint during daily activities on flat ground
- Patients confirmed by the examiner for no abnormal results in blood tests, etc.
Key exclusion criteria (17 listed)
- Patients with secondary knee osteoarthritis
- Patients with hypersensitivity reactions and serious side effects to Celebrex or Joins
- Patients with inflammatory arthritis or crystalline arthritis
- Local infection to the lower extremities of the pain area, sepsis, or previous neurological abnormalities.
- Patients who underwent meniscus surgery on the knee joint in the painful area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celebrex with Joins or notThe enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study | Drug | Celebrex + Joins, Celebrex + Placebo |
Primary outcome
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale
Time frame: changes of the WOMAC score from the first day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
6 secondary outcomes
Pain Visual Analogue Scale (VAS)
Time frame: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Brief pain inventory (BPI)
Time frame: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
SF-36 score
Time frame: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Serum Biomarker
Time frame: First day of enrollment, 12th week after enrollment, 36th week after enrollment
X-ray
Time frame: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Adverse event
Time frame: First day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celebrex with Joins or not in people with Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (82-10-9044-5228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC(Western Ontario and McMaster University Arthritis Index ) pain scale (time frame: changes of the WOMAC score from the first day of enrollment, 4th week after enrollment, 12th week after enrollment, 24th week after enrollment, 36th week after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.