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

NCT02762760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of the Hand

Interventions

BIOLOGICAL

AMPION™

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

BIOLOGICAL

Saline

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

Sponsors & Collaborators

  • Ampio Pharmaceuticals. Inc.

    lead INDUSTRY

Principal Investigators

  • David Bar-Or, MD · Ampio Pharmaceuticals. Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762760 on ClinicalTrials.gov