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Tracking Information | |
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First Received Date † | April 3, 2007 |
Last Updated Date | November 12, 2008 |
Start Date † | March 2007 |
Current Primary Outcome Measures † |
Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1 |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00456157 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |
Brief Title † | A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-Articular OP-1 in Subjects With Osteoarthritis of the Knee |
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 |
Brief Summary | The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee. |
Detailed Description | Subjects with OA will be recruited and informed consent obtained. During a screening period lasting 1 to 28 days, subjects will undergo medical and arthritis history, physical examination, collection of concomitant medications, KOOS (which contains the WOMAC questionnaire), SF-36 and global 100 mm VAS assessments, have samples obtained for urinalysis, hematology, chemistry, immunology and serum and plasma for future biomarker testing, ECG, bilateral knee x-rays and MRI of the index knee at selected sites. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized into the first cohort of 8 subjects to receive either 1.0 mL lactose (placebo) (2 subjects) or 1.0 mL OP-1 (6 subjects) intraarticularly using ultrasound or fluoroscopy guidance in an outpatient setting on day 1. Each cohort will consist of 8 treated patients, with treatment allocation in a 3:1 active-to-lactose (placebo) ratio. After an observation period of at least one hour, subjects will be released and contacted via telephone on Day 2 to query for AEs and concomitant medications. Additional follow-up visits will be done on days 7, 14, 28, 56, 84 and 168 (weeks 1, 2, 4, 8, 12 and 24) and safety and efficacy parameters evaluated according to the Schedule of Events. When a minimum of 4 weeks have elapsed since the last patient of the current cohort has been treated, all safety data will be collected and reviewed by the Principal Investigators and the Sponsor. The safety review will be conducted to ensure the demonstrated safety profile of OP-1 is acceptable for the treated patients. Only after the current dose level has been judged to be safe will dose escalation to the next dosing cohort occur. |
Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
Condition † | Osteoarthritis of the Knee |
Intervention † | Drug: Intra-articular Injection of OP-1 to affected knee |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Estimated Enrollment † | 32 |
Estimated Completion Date | December 2008 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 40 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00456157 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Stryker Biotech |
Collaborators †† | |
Investigators † | |
Information Provided By | Stryker Biotech |
Verification Date | November 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |