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Trial record 2 of 8 for:    ampion | Osteo Arthritis Knee

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

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ClinicalTrials.gov Identifier: NCT03988023
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Osteoarthritis of the Knee Biological: Ampion Other: Saline Phase 3

Detailed Description:

This study is a randomized, double-blind, single dose design. This study is conducted in male and female patients between ≥40 and 85 years of age with severe osteoarthritis of the knee. Approximately 1034 patients with severe osteoarthritis of the knee randomized 1 to 1 treatment group (1:1) will receive a single intra- injection of 4 milliliter (mL) of Ampion or saline.

The clinical effects of treatment on severe osteoarthritis of the knee will be evaluated at baseline and at 2, 4, 6, 8, 10, 12, and 24 weeks, using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1, and the Patient's Global Assessment of disease severity (PGA).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1034 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Ampion
Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection
Biological: Ampion
Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% HSA)

Placebo Comparator: Saline
Saline solution, 4 mL, single intra-articular injection
Other: Saline
Saline solution, 4 mL, single intra-articular injection




Primary Outcome Measures :
  1. Ampion improvement in pain vs. saline control. [ Time Frame: Baseline and Week 12 ]
    WOMAC A (Pain Subscale) The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  2. Ampion improvement in function vs. saline control. [ Time Frame: Baseline and Week 12 ]
    WOMAC C (Function Subscale) The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


Secondary Outcome Measures :
  1. Change in Patient's Global Assessment of Disease Severeity (PGA) [ Time Frame: Baseline and Week 12 ]

    Patient's Global Assessment of Disease Severeity (PGA)

    The PGA is a 5-point scale used to capture the participant's overall impression at the time of the assessment in the index knee. This is a single question and the score ranges from 0 to 4, where 0 anchors "very well" and 4 anchors "very poor." A negative change indicates a reduction/improvement from baseline.


  2. Change in 100 mm Visual Analogue Scale (VAS) Pain Scale [ Time Frame: Baseline and Week 12 ]

    Visual Analogue Scale (VAS) Pain Scale

    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain and collectively, using a Visual Analogue Scale 3.1, 0-100 millimeter-point scale. Higher scores on the WOMAC indicate worse pain


  3. Patient's increased or decreased use of rescue analgesia [ Time Frame: Baseline and Week 12 ]
    Patient's use of rescue analgesia, measured as amount of acetaminophen used

  4. Number of incidence and severity of treatment-emergent adverse events (TEAEs) in patients [ Time Frame: 24 weeks following a single IA Injection ]
    Incidence and severity of treatment-emergent advers events (TEAEs) in patients



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
  • Must be ambulatory
  • Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OAK and supported by radiological evidence (Kellgren-Lawrence Grade 4) that is not older than 6 months prior to the date of screening
  • Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 as measured by 5-point Likert Pain Subscale) assessed at screening
  • Ability to temporarily discontinue nonsteroidal anti-inflammatory drug (NSAID) for 48 hours prior to scheduled clinical efficacy evaluations
  • No analgesia (including acetaminophen [paracetamol]) taken 12 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
  • Use of the following medications:

    1. No IA injected pain medications in the study knee during the study
    2. No analgesics containing opioids. NSAIDs may be continued at levels preceding the study, however may not be used 48 hours prior to efficacy evaluations, and acetaminophen is available as a rescue medication during the study from the provided supply
    3. No topical treatment on osteoarthritis index knee during the study
    4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
    5. No systemic treatments that may interfere with safety or efficacy assessments during the study
    6. No immunosuppressants
    7. No use of corticosteroids > 10 mg prednisolone equivalent per day
    8. If corticosteroid use is ≤ 10 mg prednisolone equivalent per day, and if clinically indicated, subjects should be allowed to decrease their corticosteroid use. Additionally, some subjects may need to increase their steroid dose to treat worsened symptoms in the treated knee, and subjects who increase their corticosteroid dose above their starting dose of corticosteroid during the study will be treated as "treatment failures" for efficacy analysis
  • 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): NCT03988023


Contacts
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Contact: April Ramirez 720-437-6524 aramirez@ampiopharma.com
Contact: Lorena DeRienzo 720-437-6538 lderienzo@ampiopharma.com

Locations
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United States, Colorado
Denver Metro Orthopedics Recruiting
Englewood, Colorado, United States, 80113
Contact: John Schwappach, MD    303-789-3000    schwappach@dmortho.com   
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
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Principal Investigator: John R. Schwappach, M.D., FACS Lead Investigator

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Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT03988023     History of Changes
Other Study ID Numbers: AP-013
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases