A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee. In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study. Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Key facts

Study ID

NCT02184156

Run by

Ampio Pharmaceuticals. Inc.

People needed

47

Starts

2014-06-01

Expected to finish

2015-10-01

Last updated by the study team

2022-09-30

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Ambulatory
• Index knee must have been symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II-IV) acquired at Screening
• Moderate to moderately severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Pain Subscale) assessed at Screening and confirmed at randomization
• Moderate to moderately severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drugs [NSAIDs], which have not changed in the 4 weeks prior to Screening, had been used)
• No analgesia taken 24 hours before efficacy measure

You may not qualify if…

• As a result of medical review and screening investigation, the Principal Investigator considered the subject unfit for the study
• Previous Ampion injection
• Known clinically significant liver abnormality (eg, cirrhosis, transplant, etc.)
• History of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin was not an exclusion criterion)
• 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 (eg, 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
• Any pain that could interfere with the assessment of index knee pain (eg, 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 treatment or likely to be changed during the duration of the study
• Use of any of the following medications:
• IA-injected pain medications in the index knee during the study
• Analgesics containing opioids (NSAIDs were allowed at the levels preceding the study and acetaminophen was available as rescue medication during the study from the provided supply)
• Topical prescription treatment on the index knee during the study
• Significant anticoagulant therapy (eg, heparin or enoxaparin) during the study (aspirin and clopidogrel were allowed)
• Systemic treatments that could interfere with safety or efficacy assessments during the study
• Immunosuppressants
• Corticosteroids >10 mg prednisolone equivalent per day or corticosteroids at doses ≤10 mg prednisolone equivalent that had been changed during the study
• Any human albumin treatment in the 3 months before randomization

Where it is running

• Ampio Pharmaceuticals — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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