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CHRONOS - A study to learn about the effects and safety of ODM-111 in participants with long-lasting pain due to osteoarthritis of the knee.
EU CTIS ID: 2024-513553-79-00
What this study is testing
To evaluate the efficacy of ODM-111 in the treatment of chronic pain due to knee osteoarthritis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent (IC) for participation in the trial.
- Males and females ≥ 40 years of age at screening visit.
- BMI 18-40 kg/m2 at screening visit.
- A diagnosis of OA according to the American College of Rheumatology (ACR) criteria and Kellgren-Lawrence (KL) grade 2-4 in the index knee joint at the screening visit.
- OA of knee(s) is the primary painful condition and pain in the index knee joint (more symptomatic knee, appointed by the participant in case both sides equally affected) must have been present for >6 months at screening visit.
- OA pain in the index knee joint as follows: o WOMAC pain subscale (LK3.1) of [blinded information] out of 10 points at screening and baseline visits, and o weekly average of daily pain intensity [blinded information] on the 11-point NRS at baseline, based on daily assessments over at least 5 of the past 7 consecutive days preceding the baseline visit.
You likely can't join if
- A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or to communicate well with the investigator. Incapacitated persons will not be enrolled in the trial.
- Known hypersensitivity to the active substance or to any of the excipients of the study treatment.
- Females who are pregnant or lactating at screening, or planning to become pregnant within 1 month from the last dose of study treatment.
- Conditions that may involve the index joint and could confound or interfere with efficacy assessments, such as history of reactive, rheumatoid or psoriatic arthritis, ankylosing spondylitis, sarcoidosis, amyloidosis, fibromyalgia, or active infection of the index joint.
- History of joint replacement surgery in the index joint.
- History of surgery of the index joint (arthroscopic or open) within the previous year or planned during the trial.
See the full eligibility criteria
Who can join
- Signed informed consent (IC) for participation in the trial.
- Males and females ≥ 40 years of age at screening visit.
- BMI 18-40 kg/m2 at screening visit.
- A diagnosis of OA according to the American College of Rheumatology (ACR) criteria and Kellgren-Lawrence (KL) grade 2-4 in the index knee joint at the screening visit.
- OA of knee(s) is the primary painful condition and pain in the index knee joint (more symptomatic knee, appointed by the participant in case both sides equally affected) must have been present for >6 months at screening visit.
- OA pain in the index knee joint as follows: o WOMAC pain subscale (LK3.1) of [blinded information] out of 10 points at screening and baseline visits, and o weekly average of daily pain intensity [blinded information] on the 11-point NRS at baseline, based on daily assessments over at least 5 of the past 7 consecutive days preceding the baseline visit.
- ACR Functional class I-III.
- Female participants with fertile male partners, and male participants with female partners of childbearing potential, must adhere to a highly effective form of contraception (e.g. combined or progestogen only hormonal contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system), if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration, and for males from Day 1 until 3 months after the EOS visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male participants, sperm donation is not allowed until 3 months after the EOS visit.
What rules you out
- A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or to communicate well with the investigator. Incapacitated persons will not be enrolled in the trial.
- Known hypersensitivity to the active substance or to any of the excipients of the study treatment.
- Females who are pregnant or lactating at screening, or planning to become pregnant within 1 month from the last dose of study treatment.
- Conditions that may involve the index joint and could confound or interfere with efficacy assessments, such as history of reactive, rheumatoid or psoriatic arthritis, ankylosing spondylitis, sarcoidosis, amyloidosis, fibromyalgia, or active infection of the index joint.
- History of joint replacement surgery in the index joint.
- History of surgery of the index joint (arthroscopic or open) within the previous year or planned during the trial.
- Intra-articular injections of the index joint within 3 months for corticosteroid or saline and within 6 months prior to the screening visit for other injections, or planned during the trial.
- Use of analgesic treatment during the trial (from at least 10 days before the baseline visit until the last treatment visit), excluding the following: a. Paracetamol as rescue analgesia, up to 3 g daily, not within 24 hours prior to any treatment period visit. b. Acetylsalicylic acid for cardiovascular reasons, stable dosing up to 325 mg daily.
- A diagnosis of long COVID (including self-diagnosis by participant)
- Recent history of cancer (<5 years) except basal cell carcinoma or squamous cell carcinoma of the skin.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Australia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Australia. 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 EU CTIS; the study team decides eligibility.