Status:
COMPLETED
A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Phase 1: An open-label study to evaluate the safety of 3 intra-articular injections of of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 to adults with osteoarthritis (OA) knee pain. Enrollment wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02184156
Start Date
June 1 2014
End Date
October 1 2015
Last Update
September 30 2022
Active Locations (1)
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1
Ampio Pharmaceuticals
Englewood, Colorado, United States, 80112