Osteoarthritis of the Knee Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of the Knee
NCT number | NCT02556710 |
Other study ID # | AP-003-B |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | June 2016 |
Verified date | August 2022 |
Source | Ampio Pharmaceuticals. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee
Status | Completed |
Enrollment | 480 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | 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 (Kellgren Lawrence Grade II, III, or IV) read by a central reader; - WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee; - 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); - Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used); - Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed during the study); - No analgesia (including acetaminophen [paracetamol]) taken 24 hours prior to an efficacy measure; - No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.). Exclusion Criteria: - As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study - 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 - 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 osteoarthritis) - Major injury to the index knee within the 12 months prior to screening - Severe hip osteoarthritis ipsilateral to the index knee - 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) - Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study - Pregnancy or planning to become pregnant during the study. - Use of the following medications: - No IA injected pain medications in the study knee during the study - No analgesics containing opioids. - NSAIDs are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply. - No topical treatment on osteoarthritis index knee during the study - No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as low dose Aspirin and Plavix are allowed) - No systemic treatments that may interfere with safety or efficacy assessments during the study - No immunosuppressants - No use of corticosteroids - No human albumin treatment in the 3 months before randomization or throughout the duration of the study |
Country | Name | City | State |
---|---|---|---|
United States | Ampio Pharmaceuticals | Englewood | Colorado |
Lead Sponsor | Collaborator |
---|---|
Ampio Pharmaceuticals. Inc. |
United States,
Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Knee Pain | 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. | Scored at Baseline and 12 weeks | |
Secondary | Change in Knee Function | Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function. | Scored at Baseline and 12 Weeks |
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