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Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee

NCT03349645 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2022-10-03

Study results available
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Summary

This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee

Conditions

  • Severe Osteoarthritis of the Knee

Interventions

BIOLOGICAL

4 mL injection of AMPION™

4 mL injection of AMPION™

Sponsors & Collaborators

  • Ampio Pharmaceuticals. Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Levy, MD · Ampio Pharmaceuticals. Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-10-04
Completion
2018-10-04
FDA Drug
Yes

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 NCT03349645 on ClinicalTrials.gov