Status:
COMPLETED
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
Lead Sponsor:
Jiangsu XinChen-Techfields Pharma Co., LTD.
Conditions:
KNEE OSTEOARTHRITIS
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
- 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).
- 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.
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05324163
Start Date
September 29 2021
End Date
February 6 2023
Last Update
March 7 2023
Active Locations (1)
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1
China,Beijing
Beijing, China, 100005