Status:
COMPLETED
A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
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....
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).
- 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
- 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.
- Severe hip OA 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 treatment or likely to be changed during the duration of the study.
- Use of the following medications are exclusionary:
- IA injected pain medications in the study knee during the study;
- Analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply;
- Topical treatment on osteoarthritis index knee during the study;
- Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed);
- Systemic treatments that may interfere with safety or efficacy assessments during the study;
- Immunosuppressants;
- Use of corticosteroids \> 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable).
- Any human albumin treatment in the 3 months before randomization.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT02242435
Start Date
September 1 2014
End Date
May 1 2015
Last Update
September 15 2022
Active Locations (1)
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1
Ampio Pharmaceuticals, Inc.
Englewood, Colorado, United States, 80112