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An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

NCT01839331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2022-06-30

Study results available
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Summary

This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

BIOLOGICAL

4 mL injection of Ampion

4 mL Injection of Ampion

BIOLOGICAL

10 mL Injection of Ampion

10 mL Injection of Ampion

DRUG

4 mL Injection of Placebo

4 mL Injection of Placebo

DRUG

10 mL Injection of Placebo

10 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
2013-03-29
Primary Completion
2013-08-19
Completion
2013-10-31

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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 NCT01839331 on ClinicalTrials.gov