BridgeMD
A Study on Diclofenac vs. Placebo for Knee Osteoarthritis
EU CTIS ID: 2024-510757-95-01
What this study is testing
To assess the impact of a Placebo Response Mitigation Script (PRMS) on patient-reported knee pain.
- Therapeutic use (Phase IV)
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 ICF.
- Able to attend all study sessions and comply with all procedures and rules regarding allowed study medication.
- Male or female participants between the age of 40 to 85 years at the time of signing the ICF.
- Body Mass Index (BMI) less than 45 kg/m2.
- History of knee pain on most days for at least 3 months prior to screening.
- Knee pain score of at least 40 out of 100 in response to the KOOS pain questionnaire at both the screening and the baseline visits.
You likely can't join if
- Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
- History of significant knee trauma (e.g., intra-articular fracture) or knee surgery (excluding injection therapies and arthroscopy) within the previous 1 year or previous knee arthroplasty.
- Medical history and/or clinical findings (including ECG) of cardiac disease that in the opinion of the investigator are considered of clinical significance, including but not limited to established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
- Known history of hypersensitivity to Diclofenac.
- Medical history of gastrointestinal bleeding.
- Use of coumarin derivatives (e.g. warfarin).
See the full eligibility criteria
- Signed ICF.
- Able to attend all study sessions and comply with all procedures and rules regarding allowed study medication.
- Male or female participants between the age of 40 to 85 years at the time of signing the ICF.
- Body Mass Index (BMI) less than 45 kg/m2.
- History of knee pain on most days for at least 3 months prior to screening.
- Knee pain score of at least 40 out of 100 in response to the KOOS pain questionnaire at both the screening and the baseline visits.
- Kellgren-Lawrence radiological grade of ≥2 in at least one of the tibio-femoral joints diagnosed by screening fixed-flexion anterior-posterior radiograph.
- Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
- History of significant knee trauma (e.g., intra-articular fracture) or knee surgery (excluding injection therapies and arthroscopy) within the previous 1 year or previous knee arthroplasty.
- Medical history and/or clinical findings (including ECG) of cardiac disease that in the opinion of the investigator are considered of clinical significance, including but not limited to established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
- Known history of hypersensitivity to Diclofenac.
- Medical history of gastrointestinal bleeding.
- Use of coumarin derivatives (e.g. warfarin).
- Known severe kidney and/or liver function impairment.
- Pregnancy.
- Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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.