MedTrace Logo

Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

NCT03988023 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2022-10-05

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

Conditions

  • Severe Osteoarthritis of the Knee

Interventions

BIOLOGICAL

Ampion

4 mL injection of Ampion

DRUG

Saline

Saline solution, 4 mL, single intra-articular injection

Sponsors & Collaborators

  • Ampio Pharmaceuticals. Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Levy, M.D. · Ampio Pharmaceuticals. Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2021-07-13
Completion
2021-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03988023 on ClinicalTrials.gov