Status:
COMPLETED
An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of two doses of 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 two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee. Th...
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 osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
- 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
- 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)
- No analgesia (including acetaminophen \[paracetamol\]) taken 12 hours prior to an efficacy measure
- No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)
Exclusion
- 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 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 randomization or likely to be changed during the duration of the study
- Use of the following medications:
- No IA injected pain medications in the study knee during the study
- No 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
- 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 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 \> 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 :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT01839331
Start Date
March 29 2013
End Date
October 1 2013
Last Update
June 30 2022
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