Clinical trial NCT02556710: A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Osteoarthritis of the Knee
Lead sponsor: Ampio Pharmaceuticals. Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 480
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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 trial objective is to evaluate the efficacy of 4 mL of AMPION™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective is evaluation of the safety of an intra-articular injection of AMPION™.

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 (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

Primary outcomes:
measure: Change in Knee Pain
timeFrame: Scored at Baseline and 12 weeks
Secondary outcomes:
measure: Change in Knee Function
timeFrame: Scored at Baseline and 12 Weeks
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Ampio Pharmaceuticals
state: Colorado
Study officials:
affiliation: Ampio Pharmaceuticals. Inc.
name: Howard Levy, MD
role: STUDY_DIRECTOR
References:
citation: 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.