MedTrace Logo

AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

NCT03182686 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-08-09

Study results available
· View outcomes & findings →

Summary

This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee.

Conditions

Interventions

BIOLOGICAL

4 mL injection of Ampion

4 mL injection of Ampion

DRUG

4 mL Injection of Placebo

4 mL Injection of Placebo

Sponsors & Collaborators

  • Ampio Pharmaceuticals. Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Levy, MD · 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
2017-06-19
Primary Completion
2017-12-07
Completion
2017-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03182686 on ClinicalTrials.gov