A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
4 mL injection of Ampion
4 mL Injection of Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, osteoarthritis of the knee
Eligibility Criteria
Inclusion Criteria:
- Male or female, 35 years to 85 years old (inclusive) who are ambulatory but suffering from moderate to moderately severe pain from osteoarthritis in the index knee as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale at screening.
- 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, IV). Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence grading system.
- Moderate to moderately-severe OA pain in the index knee even with dosing of nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.
- No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure; and,
- 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.
Exclusion Criteria:
- Previous participation in an Ampion™ study.
- 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 OA).
- Major injury to the index knee within the 12 months prior to screening.
- Severe hip OA ipsilateral to the index knee.
- Presence of tense effusions.
- 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).
- Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
Use of the following medications anticipated to be required during the study:
- Intra-articular pain medications in the study knee
- Analgesics containing opioids. (NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply.)
- Topical treatment on osteoarthritis index knee needed during the study
- Use of significant anticoagulant therapy, oral or injectable, during the study (aspirin and clopidogrel are allowed)
- Systemic treatments that may interfere with safety or efficacy assessments during the study such as immunosuppressants
- Use of corticosteroids >10 mg prednisolone equivalent per day (if ≤10 mg prednisolone, the dose must be stable).
- Use of human albumin treatment in the 3 months before randomization.
- 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).
- Principal Investigator considers the patient unfit for the study based on medical review and screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMPION™ 4 mL dose
Placebo 4 mL dose
Arm Description
4 mL injection of Ampion
4 mL injection of placebo
Outcomes
Primary Outcome Measures
Change in WOMAC A Pain
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.
Secondary Outcome Measures
Change in WOMAC C Function
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.
Full Information
NCT ID
NCT02024529
First Posted
December 26, 2013
Last Updated
July 15, 2022
Sponsor
Ampio Pharmaceuticals. Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02024529
Brief Title
A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
Official Title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of Ampion in Adults With Pain Due to Osteoarthritis (OA) of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ampio Pharmaceuticals. Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
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 study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK).
The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, osteoarthritis of the knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
538 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMPION™ 4 mL dose
Arm Type
Experimental
Arm Description
4 mL injection of Ampion
Arm Title
Placebo 4 mL dose
Arm Type
Placebo Comparator
Arm Description
4 mL injection of placebo
Intervention Type
Biological
Intervention Name(s)
4 mL injection of Ampion
Intervention Description
4 mL injection of Ampion
Intervention Type
Drug
Intervention Name(s)
4 mL Injection of Placebo
Other Intervention Name(s)
Saline
Intervention Description
4 mL Injection of Placebo
Primary Outcome Measure Information:
Title
Change in WOMAC A Pain
Description
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.
Time Frame
Scored at Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in WOMAC C Function
Description
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.
Time Frame
Scored at Baseline and 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 35 years to 85 years old (inclusive) who are ambulatory but suffering from moderate to moderately severe pain from osteoarthritis in the index knee as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale at screening.
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, IV). Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence grading system.
Moderate to moderately-severe OA pain in the index knee even with dosing of nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.
No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure; and,
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.
Exclusion Criteria:
Previous participation in an Ampion™ study.
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 OA).
Major injury to the index knee within the 12 months prior to screening.
Severe hip OA ipsilateral to the index knee.
Presence of tense effusions.
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).
Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
Use of the following medications anticipated to be required during the study:
Intra-articular pain medications in the study knee
Analgesics containing opioids. (NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply.)
Topical treatment on osteoarthritis index knee needed during the study
Use of significant anticoagulant therapy, oral or injectable, during the study (aspirin and clopidogrel are allowed)
Systemic treatments that may interfere with safety or efficacy assessments during the study such as immunosuppressants
Use of corticosteroids >10 mg prednisolone equivalent per day (if ≤10 mg prednisolone, the dose must be stable).
Use of human albumin treatment in the 3 months before randomization.
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).
Principal Investigator considers the patient unfit for the study based on medical review and screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Levy, MD
Organizational Affiliation
Ampio Pharmaceuticals. Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29156068
Citation
Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21.
Results Reference
result
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A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
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