Your session is about to expire
← Back to Search
Other
Amniotic Suspension Allograft for Osteoarthritis
Phase 3
Waitlist Available
Research Sponsored by Organogenesis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
Study Summary
This trial is testing if aspirin is effective and safe for treating osteoarthritis symptoms in the knee.
Eligible Conditions
- Osteoarthritis of the Knee
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aspirin
Secondary outcome measures
Incidence of adverse events (AEs)
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ASAExperimental Treatment1 Intervention
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a single IA injection of 4 mL of normal saline
Find a Location
Who is running the clinical trial?
OrganogenesisLead Sponsor
35 Previous Clinical Trials
3,796 Total Patients Enrolled
2 Trials studying Osteoarthritis
210 Patients Enrolled for Osteoarthritis
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
68,885 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- may be jurors
People who are 18 years or older and are either male or female may serve on a jury.You have received a corticosteroid injection in your knee within the past 3 months before the screening.Your screening tests or physical examination show important health issues that are not specifically related to knee osteoarthritis. These issues could affect the study or make it harder to understand the results, or they may increase your risk as a participant.You have received injections or treatments for your knee within the past 6 months, such as hyaluronic acid, platelet-rich plasma, or other substances derived from your own body or from others.You take blood-thinning medication regularly.You are allergic to aspirin or any of its ingredients.You have injured your knee severely within the past 3 months.Your pain score on the WOMAC Pain scale for the past 7 days is 11 or higher.Your body weight is within a healthy range based on your height.You have symptoms like your joint getting stuck, a feeling of something blocking movement, or a sensation of something loose inside your joint, which could suggest a problem with your meniscus or loose material in your joint.She was able to keep up with the study requirements and go through all the protocol-related procedures, including post-hospitalization, out-patient, and follow-up visits.Your body weight is within a healthy range (BMI less than 40 kg/m²).You have tried at least two different treatments for your joint pain, including exercise, weight loss, and over-the-counter painkillers like acetaminophen and NSAIDs, for at least six months, but they did not work well enough.You agree to not use illegal drugs during the study and to be tested for illegal drug use if there are any suspicions.You have had consistent and significant pain in your other knee, scoring at least 4 on a pain scale, for most days in the last week.You have tried at least two different treatments for osteoarthritis that include exercise, weight loss, physical therapy, and over-the-counter pain medications like acetaminophen and nonsteroidal anti-inflammatory drugs, but they have not provided enough relief for at least 6 months.You agree not to use illegal drugs during the study and agree to be tested for illegal drug use if suspected.Must be female, surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment.If you are a man who is not surgically sterile and you want to be in the study, you must agree to use contraception from Day 1 through 12 months after you get the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ASA
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04636229 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different research sites in Canada where this project is taking place?
"The trial is being conducted out of Fremont, Nebraska, Altoona, Pennsylvania and Boston, Massachusetts with an additional 35 sites across the country."
Answered by AI
What is the maximum number of patients that can participate in this research?
"That is correct, the postings on clinicaltrials.gov state that this study is actively enrolling patients as of right now. This trial was first put up on December 14th 2020, with the most recent update being June 27th 2022. They are looking for a total of 474 people to participate at 35 different locations."
Answered by AI
Are patients currently being enrolled in this trial?
"That is correct, the listing on clinicaltrials.gov reveals that this study is open for enrollment. This particular trial was posted on December 14th 2020 and subsequently updated on June 27th 2022. In total, 474 patients are needed at 35 different enrolment sites."
Answered by AI
Are there any documented risks associated with Amniotic Suspension Allografts?
"Amniotic Suspension Allograft receives a safety score of 3 because this is a Phase 3 trial. This means that, although there is some data supporting efficacy, multiple rounds of data support safety."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
California
Other
New York
How old are they?
65+
18 - 65
What site did they apply to?
Central Research Associates
Tufts Medical Center
NYU Langone Health
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Help with my knee. MY KNEE HAS BEEN HURTING FOR YEARS.AND THIS STUDY SOUNDS REALY GOOD..
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger