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AP-003-B Study to Evaluate the Efficacy And Safety Of An Intra-Articular Injection Of Ampion™ In Adults With Pain With Osteoarthritis Of The Knee

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ClinicalTrials.gov Identifier: NCT02556710
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: AMPION™ Biological: Saline Phase 3

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 administered to subjects suffering from OA of the knee.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 4 mL AMPION™
AMPION™, 4 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.
Biological: AMPION™
4 mL Ampion Injection

Placebo Comparator: 4 mL Saline Placebo
Saline placebo, 4 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride.
Biological: Saline
4 mL Saline Injection




Primary Outcome Measures :
  1. WOMAC osteoarthritis index 3.1 [ Time Frame: Week 12 ]
    The primary trial objective is to evaluate the efficacy of 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when administered to subjects suffering from OA of the knee. Efficacy will be evaluated using the 5-Likert scale to assess change in WOMAC A from Baseline to Week 12.


Secondary Outcome Measures :
  1. Safety. Safety data will be evaluated by changes in vital sign measurements and the frequency and severity of AEs. Concomitant medication will be recorded for safety. [ Time Frame: Week 12 ]
    The secondary trial objective is evaluation of the safety of an intra-articular injection of Ampion.™ Safety data will be evaluated by changes in vital sign measurements and the frequency and severity of AEs. Concomitant medication will be recorded for safety. Safety will be assess by the Safety Monitoring Committee throughout the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 to 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556710


Locations
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United States, Colorado
Ampio Pharmaceuticals
Englewood, Colorado, United States, 80112
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
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Study Director: David Bar-Or, MD Ampio Pharmaceuticals. Inc.
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Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT02556710    
Other Study ID Numbers: AP-003-B
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Keywords provided by Ampio Pharmaceuticals. Inc.:
Osteoarthritis
Osteoarthritis of the Knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases