Diclofenac sodium for Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"- Signed ICF.\n- Able to attend all study sessions and comply with all procedures and rules regarding allowed study medication.\n- Male or female participants between the age of 40 to 85 years at the time of signing the ICF.\n- Body Mass Index (BMI) less than 45 kg/m2.\n- History of knee pain on most days for at least 3 months prior to screening.\n- 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.\n- Kellgren-Lawrence radiological grade of ≥2 in at least one of the tibio-femoral joints diagnosed by screening fixed-flexion anterior-posterior radiograph."}

Exclusion criteria

• {"criterion_text":"- Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.\n- 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.\n- 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.\n- Known history of hypersensitivity to Diclofenac.\n- Medical history of gastrointestinal bleeding.\n- Use of coumarin derivatives (e.g. warfarin).\n- Known severe kidney and/or liver function impairment.\n- Pregnancy.\n- Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study."}

Primary endpoints

• {"endpoint_text":"- Change from baseline to end of study (EoS) in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain between the active and the placebo group with the PRMS.","definition_or_measurement_approach":"Change from baseline to end of study in KOOS pain score comparing diclofenac (active) versus placebo with the Placebo Response Mitigation Script (PRMS); measured using the KOOS pain questionnaire (change from baseline to EoS)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline to EoS in KOOS pain.","definition_or_measurement_approach":"Change from baseline to end of study measured by KOOS pain score."}
• {"endpoint_text":"- Change from baseline to EoS in ICOAP constant pain, intermittent pain, and the total ICOAP score.","definition_or_measurement_approach":"Change from baseline to end of study measured by ICOAP subscales (constant pain, intermittent pain) and total ICOAP score."}
• {"endpoint_text":"- Difference in the observed standard deviation of the change from baseline to EoS in KOOS pain and ICOAP.","definition_or_measurement_approach":"Comparison of observed standard deviations of change scores from baseline to EoS in KOOS pain and ICOAP."}
• {"endpoint_text":"- Changes from baseline to EoS in pressure pain threshold (PPT) at relevant locations, temporal summation of pain (TSP), and conditioned pain modulation (CPM).","definition_or_measurement_approach":"Change from baseline to EoS measured by PPT, TSP, and CPM assessments at predefined anatomical locations."}
• {"endpoint_text":"- Change from baseline to EoS in KOOS function.","definition_or_measurement_approach":"Change from baseline to EoS measured by KOOS function score."}
• {"endpoint_text":"- Change from baseline to EoS in “40-meter walk test”.","definition_or_measurement_approach":"Change from baseline to EoS measured by performance on the 40-meter walk test."}
• {"endpoint_text":"- Change from baseline to EoS in number of placebo responders (≥30% and ≥50%).","definition_or_measurement_approach":"Proportion of subjects achieving ≥30% and ≥50% improvement from baseline to EoS in the predefined outcome measure(s)."}
• {"endpoint_text":"- Change from baseline to EoS in number of subjects meeting the OMERACT-OARSI responder criteria.","definition_or_measurement_approach":"Proportion of subjects meeting OMERACT-OARSI responder criteria at EoS compared to baseline."}

Denmark

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

27-09-2024

Processing Time Days

106

Number Of Sites

3

Number Of Participants

150

Primary sponsor

Full Name

NBCD A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark