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This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain
The study has 2 parts:
Part A: A sequential dose-escalation phase to select a well-tolerated dose of EP-104IAR. Doses to be evaluated in this phase of the study include 25, 32, 40 and 50 mg.
Part B: A parallel group phase where the highest well-tolerated dose of EP-104IAR (chosen in Part A) will be compared to placebo (vehicle).
Participants in Parts A and B will complete the same assessments. Following screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.
EP-104IAR 25 mg, EP-104IAR 32 mg, EP-104IAR 40 mg, EP-104IAR 50 mg, Vehicle
Not yet recruiting
Eupraxia Pharmaceuticals Inc.
Published on BioPortfolio: 2019-10-15T11:11:14-0400
This is a study of a OTC TFM compliant, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis (OA) knee pain (OAKP). Subjects meeting the inclusion criteria and not me...
The treatment that patients with knee OA are offered varies largely. There is a need for more evidence-based individualized guidance to treatment choice for knee osteoarthritis. This study...
This study compared the effects of tidal lavage (washing out) of the knee joint and an imitation lavage procedure in people with knee osteoarthritis. In tidal lavage, the doctor flushes ou...
To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
To describe the radiographic and symptomatic course in subjects with hip or knee complaints suspected of early osteoarthritis (OA).
Negotiating stairs is an important activity of daily living that is also associated with large loads on the knee joint. In medial compartment knee osteoarthritis, the knee adduction moment during leve...
Knee osteoarthritis (OA) affects an estimated 1 in 5 individuals older than 45 years of age in the United Kingdom. Previous studies have suggested that germanium-infused garments may provide improved ...
To investigate associations of leptin and adiponectin levels with knee and hand osteoarthritis, and explore whether these mediate the association between adiposity and osteoarthritis.
We aim to investigate if we need additional trials on exercise in knee osteoarthritis (OA) to accept a certain effect size to be a 'true' effect size, and new studies are not needed anymore.
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Injuries to the knee or the knee joint.
A region of the lower extremity immediately surrounding and including the KNEE JOINT.
Replacement for a knee joint.
Arthritis is by definition the inflammation of one or more joints, characterized by swelling, pain, warmth, redness and diminished range of joint movement (Oxford Medical Dictionary). There are many different types; Noninflammatory; Osteoarthritis, N...
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...