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This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.
This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100-200 µg CNTX-4975 | Experimental | single dose |
|
| 300-425 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses |
|
| 600-700 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses |
|
| 800 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses |
|
| 900-1000 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTX-4975 | Drug | Testing a range of dosing configurations to optimize patient tolerability |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975 | 12 Weeks | |
| Change from baseline to Week 12 in WOMAC subscale score | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William C Houghton, MD | Anesiva, Inc. | Study Director |
| Shaun Comfort, MD, MBA | Anesiva, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Phamacology Study Group | Worcester | Massachusetts | 01610 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000656706 | CNTX-4975 |
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| D012216 |
| Rheumatic Diseases |