Overview

AP-003-A A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ampio Pharmaceuticals. Inc.
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 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 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 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:

1. No IA injected pain medications in the study knee during the study

2. 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

3. No topical treatment on osteoarthritis index knee during the study

4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
(treatment such as Aspirin and Plavix are allowed)

5. No systemic treatments that may interfere with safety or efficacy assessments
during the study

6. No immunosuppressants

7. 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