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Trial record 1 of 1 for:    ap-013
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Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988023
Recruitment Status : Active, not recruiting
First Posted : June 17, 2019
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Ampion improvement in pain vs. saline control. [ Time Frame: Change in the WOMAC A pain sub score between Baseline and Week 12 ]
  • Ampion improvement in function vs. saline control [ Time Frame: Change in the WOMAC C physical function sub score between Baseline and Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Change in PGA between [ Time Frame: Baseline and Week 12 ]
  • Chage in 100 mm VAS Pain Scale between [ Time Frame: Baseline and Week 12 ]
  • Use of rescue analgesia amount of acetaminophen used between [ Time Frame: Baseline and Week 12 ]
  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 24 weeks following a single IA Injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
Official Title  ICMJE 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.
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Severe Osteoarthritis of the Knee
Intervention  ICMJE
  • Biological: Ampion
    Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% HSA)
  • Other: Saline
    Saline solution, 4 mL, single intra-articular injection
Study Arms  ICMJE
  • Experimental: Ampion
    Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution, 4 mL, single intra-articular injection
    Intervention: Biological: Ampion
  • Placebo Comparator: Saline
    Saline solution, 4 mL, single intra-articular injection
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
1034
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988023
Other Study ID Numbers  ICMJE AP-013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ampio Pharmaceuticals. Inc.
Study Sponsor  ICMJE Ampio Pharmaceuticals. Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John R. Schwappach, M.D., FACS Lead Investigator
PRS Account Ampio Pharmaceuticals. Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP