- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762760
AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint
November 11, 2016 updated by: Ampio Pharmaceuticals. Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Englewood, Colorado, United States, 80113
- Ampio Pharmaceuticals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
- 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).
Exclusion Criteria:
- 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;
- Immunosuppressants;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AMPION™
AMPION™, up to 3 mL, single intra-articular injection.
Ampion is the ultrafiltrate of 5% HSA.
|
AMPION™, up to 3 mL, single intra-articular injection.
Ampion is the ultrafiltrate of 5% HSA.
|
EXPERIMENTAL: Saline
Saline placebo, up to 3 mL, single intra-articular injection.
Saline used as the comparator is 0.9% Sodium Chloride
|
Saline placebo, up to 3 mL, single intra-articular injection.
Saline used as the comparator is 0.9% Sodium Chloride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The Clinical safety of treatment on base of the thumb will be assessed by recording AEs at all in-clinic visits and the 24-hour, post-injection telephone contact call, by the results of the physical examination of the thumb joint and vital signs (at all in-clinic visits), and by recording prior and concomitant medications including start/stop dates, indication, dose and frequency (at 24 hour post-injection telephone contact call and all in-clinic visits).
|
Baseline to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Bar-Or, MD, Ampio Pharmaceuticals. Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 4, 2016
First Posted (ESTIMATE)
May 5, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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