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Tests treatment safety and results for Moderate Pain in Knee Osteoarthritis
Official title A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07351968
What this study is testing
What is HRS-2129 Tablet?
HRS-2129 Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for moderate pain in knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Voluntarily sign the informed consent form before starting the activities related to the trial;
- The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
- people must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not...
- Male and female people of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of...
You likely can't join if
- History of other diseases that may involve the target joint;
- History of major trauma or surgery of knee joint and hip joint in the past year;
- Plan to undergo surgical procedure during the study;
- Most or complete loss of mobility;
- There are other diseases that may confuse the assessment of osteoarthritis pain;
- There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
See the full eligibility criteria
- Voluntarily sign the informed consent form before starting the activities related to the trial;
- The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
- people must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ;
- Male and female people of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of...
- History of other diseases that may involve the target joint;
- History of major trauma or surgery of knee joint and hip joint in the past year;
- Plan to undergo surgical procedure during the study;
- Most or complete loss of mobility;
- There are other diseases that may confuse the assessment of osteoarthritis pain;
- There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
- There are serious or poorly controlled concomitant diseases;
- Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
- Those who require drug treatment or surgical intervention;
- History of malignant tumors within 5 years before screening;
- Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.