KNEE OSTEOARTHRITISPhase 3NCT05324163
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
A Phase 3 study testing X0002 Spray and Celecoxib capsules in people with KNEE OSTEOARTHRITIS, run by Jiangsu XinChen-Techfields Pharma Co., LTD. at 1 site in China.
Trial summary
This study is a randomized, double-blind clinical trial in a Chinese population Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- KNEE OSTEOARTHRITIS
- What is being tested?
- X0002 Spray and Celecoxib capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2021to 6 Feb 2023
- Phase
- Phase 3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria before entering the study:
- Aged between 40 and 75 years old.
- A diagnosis of primary knee joint must be made by clinical and/or radiographic examination according to American College of Rheumatology standards
- Osteoarthritis (OA), meeting at least 4 of the following 6 criteria:
- ● Age ≥50
- Solution Number: TFR-X0002-301 Version 1.0 Date 2021-06-07
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- Rigidity lasting less than 30 minutes after waking up in the morning
- (joint) twist pronunciation
- There is bone tenderness
- Bony enlargement
- No joint heating
- 3. The history of clinical symptoms of OA of knee joint should be ≥6 months, and X-ray film of knee joint can be provided to confirm the presence of bone
- Hyperplasia or degeneration.
- 4. Knee pain during standing, walking, and/or sports for at least 14 days in the 1 month prior to screening
- Pain.
- 5. During the 7 days prior to randomization, knee pain was not treated with analgesics (study designated salvage)
- Excluding drugs), VAS score of 100mm, ≥40mm and ≤90mm for at least 5 days (as recorded on the subject's diary card).
- 6. At baseline visit (day 1), the mean WOMAC pain score for the target knee must be ≥40mm and ≤90mm.
- 7. Women in the study had to be infertile (defined as at least 1 year after menopause or having been sterilized)
- Lateral tubal ligation, bilateral oophorectomy, or total hysterectomy]), or willing to perform the following
- 1 less medically acceptable method of birth control: ● Use hormonal contraceptive methods, such as oral, implanted, injected, vaginal ring,
- Or percutaneous use of medical contraception for at least 1 full cycle (based on the subject's usual menstrual cycle).
- Intrauterine device.
- Two-barrier method (condom, sponge, or diaphragm with spermicide gel/cream).
- 8. Subjects will avoid non-habituation from the first visit during the screening period through the entire study treatment period
- Physical activity (e.g., starting a new weight lifting exercise).
- 9. Subjects were in good health except knee OA.
- 10. Subject is able to provide written signed and dated informed consent.
- 11. Be able to understand and be willing to fully comply with research process and protocol requirements.
Who cannot join
- 1. Pelecoxib, any other NSaids, aspirin, acetaminophen, sulfa drugs
- Or the presence or history of alcohol allergy; Subjects are intolerant to or have used NSAIDs regularly
- NSAIDs drugs treat OA, but the effect is not good.
- 2. Subject has a history of chronic pain (e.g., rheumatoid arthritis, psoriatic arthritis, gout joints)
- Inflammation, fibromyalgia), or other conditions that may affect the target knee function and pain assessment (e.g., bone
- Necrosis, cartilage calcification).
Show all 37Show fewer
- 3. Subjects' knee joints were secondary OA, or OA of lower limb joints other than knee joints, according to the investigator
- Judgment may affect the assessment of knee pain and function.
- 4. Have a history of knee replacement, arthroplasty or other knee surgery.
- 5. As determined by the investigator, subjects had significant injury involving the target knee in the 6 months prior to screening.
- 6. Subjects' knee joint on or near the knee during the screening period or before the first use of the investigational drug (day 1)
- Skin lesions or cuts.
- 7. Subjects had used opioids or glucocorticoid stimulation for the target knee in the 30 days prior to screening
- Element; Or requiring long-term treatment with opioids or glucocorticoids during the study period.
- 8. Subjects received intraknee injections of steroids, hyaluronic acid, or adhesives within 3 months prior to screening
- (e.g., Cinvicol ®).
- 9. Subjects had asthma and required systemic glucocorticoid therapy (only with inhaled glucocorticoid therapy)
- Asthma patients are eligible).
- 10. Subjects 1 month prior to screening, except for aspirin not exceeding 325 mg/ day for heart disease prevention
- He was given antithrombotic drugs.
- 11. Subjects had active peptic ulcer in the 6 months prior to screening or gastrointestinal tract in the 5 years prior to screening
- A history of blood.
- 12. Subject is receiving systemic chemotherapy for any type of active malignancy; Or 5 years prior to screening
- Within, cancer was diagnosed (but not squamous cell carcinoma or basal cell carcinoma of the skin).
- 13. Subject will, in the investigator's judgment, have any clinically significant cardiac, respiratory, or mental instability
- Diseases of the menstrual, immunological, blood, or kidney, or other physical, medical, ecg, or laboratory tests
- Abnormalities of clinical significance that affect the evaluation of safety and efficacy. Defined as:
- ● Detection value of aspartate aminotransferase, alanine aminotransferase and lactate dehydrogenase ≥3× upper limit of normal value [ULN]; ● Creatinine or total bilirubin ≥1.5 × ULN; ● Hemoglobin < 10g/dL; ● Screening visit, or baseline visit (day 1). Fecal occult blood test is positive; ● Ecg abnormalities with clinical significance, including but not limited to QTc interphase abnormalities (QTc prolongidine)
- Meaning male or female > 480 ms);
- ● uncontrolled hypertension was defined as systolic blood pressure > 170mmHg or diastolic blood pressure > 105 mmHg.
- 14. Subjects known to abuse alcohol or other drugs.
- 15. Subjects have participated in a clinical trial for brothamine hydrochloride spray or have participated in any of the trials within 1 month prior to screening
- Other clinical trials, or screening fashionable drugs in other clinical trials within the 5 metabolic half-lives.
- 16. Female subjects, who are pregnant, planning to be pregnant, or breastfeeding.
- 17. The subject has an employee or immediate family relationship with the investigator.
- 18. Subject is unable to make or receive phone calls and/or is technically unavailable.
- 19. The investigator considered that the subject had conditions that were inappropriate for clinical trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
This study is a randomized, double-blind clinical trial in a Chinese population
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-positive, phase iii study evaluating the efficacy and safety of brothamine hydrochloride spray in patients with knee osteoarthritis
- Conditions
- KNEE OSTEOARTHRITIS
- Being tested
- X0002 Spray, Celecoxib capsules, placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X0002 SprayDrug
Also called Test drug
X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day
Celecoxib capsulesDrug
Also called Active comparator
X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day
placeboDrug
Also called Placebo Spray
X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
| Study group | Role | What they receive |
|---|---|---|
| X0002 spray group | Experimental | X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day Receives: Drug: X0002 Spray; Drug: placebo |
| Celecoxib capsule Group: | Active comparator | X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day Receives: Drug: Celecoxib capsules; Drug: placebo |
| The placebo group | Placebo comparator | X0002 spray placebo 17.5 mg, twice a day; Celecoxib placebo 200mg, once a day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ibuprofen hydrochloride spray in the treatment of subjects' target knee osteoarthritis when compared with celecoxib capsules at 12 weeks of treatment with ibuprofen hydrochloride spray.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week 12
Secondary outcomes (7)
Changes in WOMAC pain Scale scores for OA of the target knee compared to baseline at 1, 2, 4, and 8 weeks of treatment
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, changes in the WOMAC Rigidity Scale score for OA of the target knee compared to baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
Changes in WOMAC Daily Activity Scale scores for target knee OA compared to baseline at weeks 1, 2, 4, 8, and 12 of treatment
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
Changes in total WOMAC score for knee OA at 1, 2, 4, 8, and 12 weeks of treatment compared to baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, subjects self-assessed changes in OA of the target knee compared to baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, subjects themselves assessed the response of target knee OA to treatment (compared to baseline)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
Changes in daily doses of salvage analgesics (acetaminophen) compared to baseline at 1, 2, 4, 8, and 12 weeks of treatment
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
Measured: week1、week2、week4、week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start29 Sep 2021
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KNEE 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu XinChen-Techfields Pharma Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiaofeng zeng, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324163
- Sponsor's protocol ID
- TFR-X0002-301
- Status last verified
- May 2022
- First submitted
- 5 Apr 2022
- Last updated
- 7 Mar 2023
- Results posted
- 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05324163
- Acronym / sponsor ID
- TFR-X0002-301
- Conditions
- KNEE OSTEOARTHRITIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jiangsu XinChen-Techfields Pharma Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 12 Apr 2022 (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.
This study is a randomized, double-blind clinical trial in a Chinese population
Detailed description
This is a multicenter, randomized, double-blind, placebo-positive, phase iii study evaluating the efficacy and safety of brothamine hydrochloride spray in patients with knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| X0002 spray group | Experimental | Drug: X0002 Spray, Drug: placeboX0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day |
| Celecoxib capsule Group: | Active comparator | Drug: Celecoxib capsules, Drug: placeboX0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day |
| The placebo group | Placebo comparator | Drug: placeboX0002 spray placebo 17.5 mg, twice a day; Celecoxib placebo 200mg, once a day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects must meet all of the following inclusion criteria before entering the study:
- ● Age ≥50
- Solution Number: TFR-X0002-301 Version 1.0 Date 2021-06-07
- 3. The history of clinical symptoms of OA of knee joint should be ≥6 months, and X-ray film of knee joint can be provided to confirm the presence of bone
- Hyperplasia or degeneration.
Key exclusion criteria (37 listed)
- 1. Pelecoxib, any other NSaids, aspirin, acetaminophen, sulfa drugs
- Or the presence or history of alcohol allergy; Subjects are intolerant to or have used NSAIDs regularly
- NSAIDs drugs treat OA, but the effect is not good.
- 2. Subject has a history of chronic pain (e.g., rheumatoid arthritis, psoriatic arthritis, gout joints)
- Inflammation, fibromyalgia), or other conditions that may affect the target knee function and pain assessment (e.g., bone
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 |
|---|---|---|
| X0002 SprayAlso: Test drugX0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day | Drug | X0002 spray group |
| Celecoxib capsulesAlso: Active comparatorX0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day | Drug | Celecoxib capsule Group: |
| placeboAlso: Placebo SprayX0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day | Drug | Celecoxib capsule Group:, The placebo group, X0002 spray group |
Primary outcome
To evaluate the efficacy of ibuprofen hydrochloride spray in the treatment of subjects' target knee osteoarthritis when compared with celecoxib capsules at 12 weeks of treatment with ibuprofen hydrochloride spray.
Time frame: week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
7 secondary outcomes
Changes in WOMAC pain Scale scores for OA of the target knee compared to baseline at 1, 2, 4, and 8 weeks of treatment
Time frame: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, changes in the WOMAC Rigidity Scale score for OA of the target knee compared to baseline
Time frame: week1、week2、week4、week8
Changes in WOMAC Daily Activity Scale scores for target knee OA compared to baseline at weeks 1, 2, 4, 8, and 12 of treatment
Time frame: week1、week2、week4、week8
Changes in total WOMAC score for knee OA at 1, 2, 4, 8, and 12 weeks of treatment compared to baseline
Time frame: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, subjects self-assessed changes in OA of the target knee compared to baseline
Time frame: week1、week2、week4、week8
At 1, 2, 4, 8, and 12 weeks of treatment, subjects themselves assessed the response of target knee OA to treatment (compared to baseline)
Time frame: week1、week2、week4、week8
Changes in daily doses of salvage analgesics (acetaminophen) compared to baseline at 1, 2, 4, 8, and 12 weeks of treatment
Time frame: week1、week2、week4、week8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- 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.
xiaofeng zeng principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing X0002 Spray and Celecoxib capsules in people with KNEE OSTEOARTHRITIS, run by Jiangsu XinChen-Techfields Pharma Co., LTD. at 1 site in China.
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 29 inclusion and 37 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: finished, as of the sponsor's last update on 7 Mar 2023. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of ibuprofen hydrochloride spray in the treatment of subjects' target knee osteoarthritis when compared with celecoxib capsules at 12 weeks of treatment with ibuprofen hydrochloride spray. (time frame: week 12). 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 7 Mar 2023.