Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
NCT ID: NCT05324163
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2021-09-29
2023-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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X0002 spray group
X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day
X0002 Spray
X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day
placebo
X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
Celecoxib capsule Group:
X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day
Celecoxib capsules
X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day
placebo
X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
The placebo group
X0002 spray placebo 17.5 mg, twice a day; Celecoxib placebo 200mg, once a day
placebo
X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
Interventions
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X0002 Spray
X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day
Celecoxib capsules
X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day
placebo
X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
* 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.
Exclusion Criteria
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).
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.
40 Years
75 Years
ALL
No
Sponsors
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Jiangsu XinChen-Techfields Pharma Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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xiaofeng zeng
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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China,Beijing
Beijing, , China
Countries
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Other Identifiers
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TFR-X0002-301
Identifier Type: -
Identifier Source: org_study_id
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