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Intra-articular of OP-1 to affected knee

Phase 1

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |Stryker Corporation|Trials Updated: Jun 17, 2010

Intra-articular of OP-1 to affected knee target and mechanism

ModalitySmall molecule

Also known as Intra-articular Injection of OP-1 to affected knee

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Intra-articular of OP-1 to affected knee clinical trials

Intra-articular of OP-1 to affected knee · 1 trial · 1 indication

Phase 1 1
NCT00456157A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the KneeOsteoarthritis of the Knee
COMPLETED33 Analytics
PHASE1COMPLETED
A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee
Osteoarthritis of the Knee
NCT0045615733
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Study Endpoints

Primary Endpoints

Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1

Secondary Endpoints

Determine the proportion of patients with 20%, 50%, and 70% improvement in the Western Ontario and McMaster (WOMAC) pain, and function subscales at 4, 8, 12, and 24 weeks.
Determine the change from baseline to 4, 8, 12, and 24 weeks in the pain, other symptoms, function in daily living, function in sports and recreation and knee related quality of life subscales of the Knee and Osteoarthritis Outcome Score (KOOS) survey.
Determine the change from baseline to 4, 8, 12, and 24 weeks in the patient's global assessment and disease status and physician's global assessment and disease status using the 100-mm visual-analogue scale (VAS).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Intra-articular Injection of OP-1 to affected kneeDRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain, and may include crepitus, swelling and/or effusion of the knee. In subjects with bilateral knee OA, the more...

Countries:United States
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Competitive Landscape -Osteoarthritis 143 trials (matched to "Osteoarthritis of the Knee")

Top 5 of 14 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO2PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra
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Frequently asked questions about Intra-articular of OP-1 to affected knee

What is intra-articular OP-1 used for in osteoarthritis of the knee?

Intra-articular OP-1 is an investigational small molecule given by injection into the knee joint to treat osteoarthritis of the knee. It was studied as a single escalating dose in adults aged 40 and older with the condition. It is not an approved therapy and remains in clinical development.

Who is developing intra-articular OP-1 for knee osteoarthritis?

Stryker Corporation, which trades on the New York Stock Exchange under the ticker SYK, is the developer of intra-articular OP-1 for osteoarthritis of the knee. The company sponsored the Phase 1 study of the agent conducted in the United States.

What phase is intra-articular OP-1 in for knee osteoarthritis?

Intra-articular OP-1 is in Phase 1 development for osteoarthritis of the knee. The single Phase 1 trial has been completed, and no active trials of the agent are listed. It is investigational and has not been approved for any indication.

What clinical trial has studied intra-articular OP-1 in knee osteoarthritis?

One clinical trial has studied intra-articular OP-1: NCT00456157, titled A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee. It enrolled 33 participants in the United States, was randomized and double-blind, and is completed.

Is intra-articular OP-1 the same as intra-articular injection of OP-1 to the affected knee?

Yes. Intra-articular OP-1 and intra-articular injection of OP-1 to the affected knee refer to the same investigational treatment for osteoarthritis of the knee. Both names describe the same Stryker Corporation program studied in the completed Phase 1 trial NCT00456157.

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