A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

August 5, 2022 updated by: Ampio Pharmaceuticals. Inc.

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of the Knee

This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee

Study Overview

Detailed Description

A Randomized, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

The primary trial objective is to evaluate the efficacy of 4 mL of AMPION™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective is evaluation of the safety of an intra-articular injection of AMPION™.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Englewood, Colorado, United States, 80112
        • Ampio Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide written informed consent to participate in the study;
  • Willing and able to comply with all study requirements and instructions of the site study staff;
  • Male or female, 40 years to 85 years old (inclusive);
  • Must be ambulatory;
  • Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, or IV) read by a central reader;
  • WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;
  • Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale);
  • Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used);
  • Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed during the study);
  • No analgesia (including acetaminophen [paracetamol]) taken 24 hours prior to an efficacy measure;
  • No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).

Exclusion Criteria:

  • As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
  • A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
  • A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
  • Presence of tense effusions
  • Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
  • Isolated patella femoral syndrome, also known as chondromalacia
  • Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
  • Major injury to the index knee within the 12 months prior to screening
  • Severe hip osteoarthritis ipsilateral to the index knee
  • Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
  • Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
  • Pregnancy or planning to become pregnant during the study.
  • Use of the following medications:
  • No IA injected pain medications in the study knee during the study
  • No analgesics containing opioids.
  • NSAIDs are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply.
  • No topical treatment on osteoarthritis index knee during the study
  • No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as low dose Aspirin and Plavix are allowed)
  • No systemic treatments that may interfere with safety or efficacy assessments during the study
  • No immunosuppressants
  • No use of corticosteroids
  • No human albumin treatment in the 3 months before randomization or throughout the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMPION™ 4 mL dose
4 mL injection of Ampion
4 mL Injection of Ampion
Placebo Comparator: Placebo 4 mL dose
4 mL Injection of Placebo
4 mL Injection of Placebo
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Pain
Time Frame: Scored at Baseline and 12 weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Scored at Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Function
Time Frame: Scored at Baseline and 12 Weeks
Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.
Scored at Baseline and 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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