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Study terminated early due to decision by sponsor
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The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durolane | Experimental | Single intraarticular injection of Durolane |
|
| PBS | Placebo Comparator | Single intraarticular injection of PBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durolane | Device | 4.5 mL |
| |
| PBS |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain. | Up to 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nebojsa Skrepnik, MD, PhD | Tucson Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Durolane | Single intraarticular injection of Durolane Durolane |
| FG001 | Phosphate Buffered Saline (PBS) | Single intraarticular injection of PBS PBS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
4.5 mL |
|
| Mobile |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Hot Springs | Arkansas | United States |
| Beverly Hills | California | United States |
| El Cajon | California | United States |
| Boulder | Colorado | United States |
| Danbury | Connecticut | United States |
| Trumbull | Connecticut | United States |
| Lauderdale Lakes | Florida | United States |
| Pinellas Park | Florida | United States |
| South Miami | Florida | United States |
| Boise | Idaho | United States |
| Meridian | Idaho | United States |
| Evansville | Indiana | United States |
| New Orleans | Louisiana | United States |
| Wheaton | Maryland | United States |
| Kalamazoo | Michigan | United States |
| Springfield | Missouri | United States |
| Oklahoma City | Oklahoma | United States |
| Duncansville | Pennsylvania | United States |
| Wyomissing | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Norfolk | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Durolane | Single intraarticular injection of Durolane Durolane |
| BG001 | Phosphate Buffered Saline (PBS) | Single intraarticular injection of PBS PBS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Change in WOMAC VAS Pain Score From Week 6 to Week 30 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain. | Posted | Mean | Standard Deviation | units on a scale | Up to 30 weeks |
|
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Durolane | Single intraarticular injection of Durolane Durolane | 1 | 37 | 2 | 37 | 15 | 37 |
| EG001 | Phosphate Buffered Saline (PBS) | Single intraarticular injection of PBS PBS | 0 | 38 | 1 | 38 | 13 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Not related to study product or injection procedure; Resulted in death |
| ||
| Cardiac failure congestive | Cardiac disorders | Not related to study product or injection procedure |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Not related to study product or injection procedure |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Not related to study product or injection procedure |
| ||
| Pneumonia | Infections and infestations | Not related to study product or injection procedure; Pre-treatment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site joint pain | General disorders | Definitely, probably, or possibly related to the study product and/or injection procedure |
| ||
| Injection site pain | General disorders | Definitely, probably, or possibly related to the study product and/or injection procedure |
| ||
| Injection site erythema | General disorders | Definitely, probably, or possibly related to the study product and/or injection procedure |
| ||
| Meniscus injury | Injury, poisoning and procedural complications | Not related to study product or injection procedure |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Not related to study product or injection procedure |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | One event in Durolane group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The other events not related to study product or injection procedure. |
| ||
| Joint stiffness | Musculoskeletal and connective tissue disorders | Both events in Durolane group and 1 event in PBS group definitely, probably, or possibly related to the study product and/or injection procedure. 1 event in PBS group not related to study product or injection procedure. |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | 6 events in Durolane group and 1 event in PBS group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The rest of the events not related to study product or injection procedure. |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Not related to study product or injection procedure |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 1 event in PBS group assessed as definitely, probably, or possibly related to the study product and/or injection procedure. The rest of the events not related to study product or injection procedure. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46 18 4749000 | reception.seupp@galderma.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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