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Lorecivivint for Osteoarthritis
Study Summary
This trial will study the long-term effects of a drug called lorecivivint on people with knee osteoarthritis. The first part of the study will be placebo-controlled (meaning some people will take a fake pill), but after that it will be open-label (meaning everyone will take the real drug).
- Osteoarthritis of the Knee
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 700 Patients • NCT03122860Trial Design
Who is running the clinical trial?
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- You have completed the Samumed study SM04690-OA-11.You understand the ICF and are willing to sign it.
- Group 1: Arm 1
- Group 2: Arm 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Are people of all ages being accepted for this trial, or are there age restrictions?
"According to the inclusionary age parameters set for this particular trial, eligible participants must be between 41 and 81 years old."
What is the historical context of this research?
"Lorecivivint is only being studied in one active trial across 47 cities and 1 country. The first study for Lorecivivint was run in 2020 by Biosplice Therapeutics, Inc. That initial Phase 3 drug approval stage involved 276 participants and completed successfully. Since then, a total of 18290 trials have been conducted."
How many research participants are needed for this project?
"This research is no longer enrolling patients. The trial was announced on 8/25/2020 and the last update was on 4/14/2022. For those still searching, there are 724 ongoing trials for osteoarthritis, knee and 1 study for Lorecivivint that are presently recruiting individuals."
What are the ineligibility requirements for this clinical trial?
"The requirements for patients that wish to enroll in this study are as follows: a diagnosis of osteoarthritis, knee pain, and an age between 41 and 81. This clinical trial has space for 276 individuals in total."
Does this research project have positions open in more than one city?
"Currently, this study is enrolling patients at 27 clinical sites. The locations of these facilities are listed on the website and include major cities such as New Orleans, Winston-Salem and Winter Haven. Additionally, there are 27 other locations spread out across different cities. If you choose to enroll in this study, try to select a clinic that is nearest to your location to minimize travel requirements."
What does this clinical trial aim to achieve?
"According to the sponsor of this trial, Biosplice Therapeutics, Inc., the primary outcome will be safety-related. This will be measured by observing any adverse effects or serious adverse events that occur over the course of the study in relation to a parent-study baseline. Additionally, secondary outcomes being assessed include changes in physical function as determined by subscores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Another metric for change that will be monitored is joint space width as observed via X-ray radiograph."
What are the possible side effects of Lorecivint?
"There is some evidence for efficacy and multiple data sets indicating safety, so our team has given Lorecivint a score of 3."
What are some of the other areas in which Lorecivivint has been studied?
"At present, there is 1 ongoing clinical trial evaluating the efficacy of Lorecivivint. This particular study is in Phase 3. In addition, 47 medical facilities across the globe are currently running trials for this medication with many of them being based in Las Vegas, Nevada."
Are there any open slots left for this research project?
"The specified trial is no longer recruiting patients. According to the information available, it was first posted on 8/25/2020 and last edited on 4/14/2022. There are presently 724 clinical trials actively looking for participants with osteoarthritis and 1 study for Lorecivivint that needs participants."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
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Most responsive sites:
- Research Site: < 24 hours
Average response time
- < 2 Days
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