A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee
Overview
- Phase
- Phase 3
- Intervention
- 4 mL injection of Ampion
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- Ampio Pharmaceuticals. Inc.
- Enrollment
- 342
- Locations
- 1
- Primary Endpoint
- Change in Knee Pain
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
Detailed Description
A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee. The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK). The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide written informed consent to participate in the study.
- •Willing and able to comply with all study requirements and instructions of the site study staff.
- •Male or female, 40 years to 85 years old (inclusive).
- •Must be ambulatory.
- •Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (x-ray) acquired at screening and assessed by a central reader. Subjects must have a Kellgren Lawrence Grade of III or IV for inclusion in the study.
- •Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC® Index 3.1 5-point Likert Pain Subscale) assessed at screening and confirmed at randomization.
- •Moderate to moderately-severe OA pain in the index knee (even if chronic doses of non-steroidal anti-inflammatory drug \[NSAID\], which have not changed in the 4 weeks prior to screening, have been/are being used).
- •No analgesia taken 24 hours before efficacy measure.
Exclusion Criteria
- •As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
- •Previous Ampion™ injection in the index knee.
- •Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).
- •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).
- •Presence of tense effusions in the index knee.
- •Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator.
- •Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.
- •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.
Arms & Interventions
Ampion 4ml dose
4 mL intra-articular injection of Ampion
Intervention: 4 mL injection of Ampion
Placebo Solution
4 mL placebo intra-articular injection
Intervention: 4 mL Injection of Placebo
Outcomes
Primary Outcomes
Change in Knee Pain
Time Frame: Scored at Baseline and 20 Weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Secondary Outcomes
- Change in Knee Function(Scored at Baseline and 20 Weeks)