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Bone morphogenetic protein 7

Phase 2

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |Stryker Corporation|Last Updated: Feb 1, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment406

FDA Designations

No designations recorded

Clinical trial landscape

Bone morphogenetic protein 7 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01111045Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the KneeOsteoarthritis of the Knee
COMPLETED355 Analytics
PHASE2COMPLETED
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
Osteoarthritis of the KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Baseline, and at 24 weeks
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

Secondary Endpoints

WOMAC pain and function
Baseline, Week 4, Week 8, Week 12, Week 24
Patient and physician global VAS
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Quality of life measurement (SF-36) and pain medication use
Baseline, Week 4, Week 8, Week 12, Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR0.03 mg/ml BMP-7, single intraarticular knee injection
Arm 2ACTIVE_COMPARATOR0.1 mg/ml BMP-7, single intraarticular knee injection
Arm 3ACTIVE_COMPARATOR0.3 mg/ml BMP-7, single intraarticular knee injection
Arm 4PLACEBO_COMPARATOR1 ml placebo, single intraarticular knee injection (control)
Cohort 1EXPERIMENTAL0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
Cohort 2EXPERIMENTAL0.1 mg/ml BMP-7 or placebo via intraarticular knee injection
Cohort 3EXPERIMENTAL0.3 mg/ml BMP-7 or placebo via intraarticular knee injection

Interventions

NameTypeDescription
Bone morphogenetic protein 7DRUGComparison of different doses of the drug via single intraarticular knee injection
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Ambulatory with a diagnosis of 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. * A male or female adult age \>40 years * female subjects of childbearing potential must have a negati...

Countries:United States
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Frequently asked questions about Bone morphogenetic protein 7

What is Bone morphogenetic protein 7 used for?

Bone morphogenetic protein 7 is an investigational small molecule being developed for osteoarthritis of the knee. It is administered intraarticularly and is currently in clinical development, with completed Phase 1 and Phase 2 trials. It is not approved by the FDA and remains investigational.

Who makes Bone morphogenetic protein 7?

Bone morphogenetic protein 7 is being developed by Stryker Corporation, which trades under the ticker SYK. The company has conducted clinical trials for this drug in the United States for osteoarthritis of the knee.

What phase is Bone morphogenetic protein 7 in?

Bone morphogenetic protein 7 is in Phase 2 clinical development. It has completed a Phase 2 dose-finding study and a Phase 1 safety study, both in patients with osteoarthritis of the knee. The drug is investigational and not yet approved.

What clinical trials is Bone morphogenetic protein 7 in?

Bone morphogenetic protein 7 has completed two clinical trials: NCT01111045, a Phase 2 dose-finding study with 355 participants, and NCT01133613, a Phase 1 single-dose escalation safety study with 51 participants. Both trials were conducted in the United States in patients with knee osteoarthritis.

How does Bone morphogenetic protein 7 work?

Bone morphogenetic protein 7 is a small molecule that targets bone morphogenetic protein 7, a protein involved in bone and cartilage formation. In osteoarthritis of the knee, it is being studied for its potential to modify the disease process, though its exact mechanism in this context is not fully detailed.