CompletedPhase 1

AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint

United States15 participantsStarted 2016-05

Plain-language summary

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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use

Timeframe: Baseline to 4 weeks

Trial details

NCT IDNCT02762760

SponsorAmpio Pharmaceuticals. Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Osteoarthritis of the Hand trials