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This study is a randomized, double-blind clinical trial in a Chinese population
Full 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
Enrollment
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Inclusion criteria
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
Hyperplasia or degeneration.
Pain.
Excluding drugs), VAS score of 100mm, ≥40mm and ≤90mm for at least 5 days (as recorded on the subject's diary card).
At baseline visit (day 1), the mean WOMAC pain score for the target knee must be ≥40mm and ≤90mm.
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).
Physical activity (e.g., starting a new weight lifting exercise).
Subjects were in good health except knee OA.
Subject is able to provide written signed and dated informed consent.
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.
Inflammation, fibromyalgia), or other conditions that may affect the target knee function and pain assessment (e.g., bone
Necrosis, cartilage calcification).
Judgment may affect the assessment of knee pain and function.
Have a history of knee replacement, arthroplasty or other knee surgery.
As determined by the investigator, subjects had significant injury involving the target knee in the 6 months prior to screening.
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.
Element; Or requiring long-term treatment with opioids or glucocorticoids during the study period.
(e.g., Cinvicol ®).
Asthma patients are eligible).
He was given antithrombotic drugs.
A history of blood.
Within, cancer was diagnosed (but not squamous cell carcinoma or basal cell carcinoma of the skin).
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.
Subjects known to abuse alcohol or other drugs.
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.
Female subjects, who are pregnant, planning to be pregnant, or breastfeeding.
The subject has an employee or immediate family relationship with the investigator.
Subject is unable to make or receive phone calls and/or is technically unavailable.
The investigator considered that the subject had conditions that were inappropriate for clinical trial participation.
Primary purpose
Allocation
Interventional model
Masking
180 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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