A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee (Knee OA)
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|ClinicalTrials.gov Identifier: NCT00456157|
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : June 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Drug: Intra-articular Injection of OP-1 to affected knee||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular Osteogenic Protein-1 OP-1 in Subjects With Osteoarthritis of the Knee|
|Study Start Date :||March 2007|
|Actual Study Completion Date :||November 2008|
- Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1
- 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).
- Quality of life measured by the Short Form (SF)-36 at baseline and 4, 8,12 and 24 weeks
- Amount of rescue medications required at 4, 8, 12 and 24 weeks
- Knee cartilege and surrounding saft tissue changes by magnetic resonance imaging (MRI) of the index knee and proteoglycan content by delayed gadolinium enhanced MRI of cartilage (dGEMRIC)
- Analysis of efficacy data using the Outcome Measures in Arthritis Clinical Trials -Osteoarthritis Research Society (OMERACT-OARSI) Responder Index
- Blood levels of OP-1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456157
|United States, Massachusetts|
|Tufts-New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118-2526|
|United States, North Carolina|
|University of orth Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27599-7280|