NCT02762760

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

May 2, 2016

Last Update Submit

November 11, 2016

Conditions

Osteoarthritis of the Hand

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (2)

AMPION™

EXPERIMENTAL

AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.

Biological: AMPION™

Saline

EXPERIMENTAL

Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride

Biological: Saline

Interventions

AMPION™BIOLOGICAL

AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.

AMPION™
SalineBIOLOGICAL

Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride

Saline

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 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.
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ampio Pharmaceuticals

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Interventions

aspartyl-alanyl-diketopiperazineSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • David Bar-Or, MD

    Ampio Pharmaceuticals. Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 5, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-10

Locations

US(1)