Knee osteoarthritis injection study halted early
NCT ID NCT04931667
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an injection called lorecivivint for people with knee osteoarthritis. The goal was to see if it safely reduces pain and improves knee function over three years. The study was stopped early and included 72 adults aged 40 to 80.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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72 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Dec 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA 2. Femorotibial OA by standard American College of Rheumatology (ACR) criteria; knee OA is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis). 3. Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit 4. Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, and benzodiazepine, unless any of these drugs are prescribed by a physician to treat a specific condition 5. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments 6. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed Exclusion Criteria: 1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Screening and Day 1 2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period 3. Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1 4. Intra-articular (IA) injection into either knee with a therapeutic aim including, but not limited to, hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1 or IA glucocorticoids within 12 weeks prior to Day 1 5. Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation 6. Any comorbid condition that could affect study endpoint assessments of the knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia 7. Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Tucson, Arizona, 85712, United States
-
Research Site
Winter Park, Florida, 32789, United States
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Research Site
Oak Brook, Illinois, 60523, United States
-
Research Site
Dallas, Texas, 75231, United States
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Other studies related to the condition(s) this trial covers.
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