Status and phase
Conditions
Treatments
About
This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
Full description
A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
The primary study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK).
The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Previous participation in an Ampion™ study.
Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the principal investigator.
Isolated patella femoral syndrome, also known as chondromalacia.
Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g., cancer, congenital defects, spine OA).
Major injury to the index knee within the 12 months prior to screening.
Severe hip OA ipsilateral to the index knee.
Presence of tense effusions.
Any pain that could interfere with the assessment of index knee pain (e.g., pain in any other part of the lower extremities, pain radiating to the knee).
Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
Use of the following medications anticipated to be required during the study:
Use of corticosteroids >10 mg prednisolone equivalent per day (if ≤10 mg prednisolone, the dose must be stable).
Use of human albumin treatment in the 3 months before randomization.
A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
Principal Investigator considers the patient unfit for the study based on medical review and screening.
Primary purpose
Allocation
Interventional model
Masking
538 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal