AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint
This trial has been completed.
|Condition||osteoarthritis of the hand|
|Sponsor||Ampio Pharmaceuticals. Inc.|
|Start date||May 2016|
|End date||November 2016|
|Trial size||15 participants|
|Trial identifier||NCT02762760, AP-011|
This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use
time frame: Baseline to 4 weeks
Male or female participants from 40 years up to 85 years old.
- 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).
- Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
- Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).
- As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
- Previous Ampion™ injection.
- 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).
- Women who are currently pregnant or who could become pregnant.
- Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
- Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
- Major injury to the index thumb within the 12 months prior to screening.
- 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 thumb during the study;
- Analgesics containing opioids;
- NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
- Topical prescription treatment on osteoarthritis index thumb during the study;
- Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
- Systemic treatments that may interfere with safety or efficacy assessments during the study;
- Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
- Any human albumin treatment in the 3 months before randomization.
|Official title||A Prospective Phase I Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ as a Treatment for Arthritis of the Basal Thumb Joint|
|Description||A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint. Primary Objective is: To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.|
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