A Study on Diclofenac vs. Placebo for Knee Osteoarthritis

Phase 1

• Conditions: Knee osteoarthritis; MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2024-510757-95-01
• Lead Sponsor: BCD A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified