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Intra-articular of OP-1 to affected knee

Phase 1

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

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

Clinical trial landscape

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 114 trials (matched to "Osteoarthritis of the Knee")

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra
Smith & Nephew plc Sponsored ADRSNN9 - Undisclosed
Stryker CorporationSYK11N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57N/AUndisclosed
Merit Medical Systems, Inc.MMSI1N/ACorticosteroid
Johnson & JohnsonJNJ1N/AUndisclosed
Abbott LaboratoriesABT1N/AUndisclosed
Enovis CorporationENOV1N/AUndisclosed
Teleflex IncorporatedTFX1 - Undisclosed
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Frequently asked questions about Intra-articular of OP-1 to affected knee

What is Intra-articular of OP-1 to affected knee used for?

Intra-articular of OP-1 to affected knee is an investigational small molecule being studied for osteoarthritis of the knee. It is administered directly into the affected knee joint. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes Intra-articular of OP-1 to affected knee?

Stryker Corporation (NYSE: SYK) is developing Intra-articular of OP-1 to affected knee. The company is conducting clinical trials to evaluate the safety of this investigational treatment for osteoarthritis of the knee.

What phase is Intra-articular of OP-1 to affected knee in?

Intra-articular of OP-1 to affected knee is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is Intra-articular of OP-1 to affected knee in?

Intra-articular of OP-1 to affected knee has one completed clinical trial, NCT00456157. This was a Phase 1, double-blind, randomized, single dose escalation safety study in 33 subjects with osteoarthritis of the knee in the United States.

Is Intra-articular of OP-1 to affected knee FDA approved?

No, Intra-articular of OP-1 to affected knee is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for osteoarthritis of the knee. The completed Phase 1 trial focused on safety evaluation.