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The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac sodium topical gel 1% | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium topical gel 1% | Drug | Diclofenac sodium topical gel 1%, 4 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on Movement | Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain" | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on Movement | Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain" | 24 hours and 7 days |
| Onset of Pain Relief |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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Study Start 30 Nov 2010 Study end 17 Juin 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Sodium Topical Gel 1% | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo, 4 times daily |
|
Onset of perceptible pain relief
| Day 1 |
| Tenderness | Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness. | Change from baseline at 24 and 72 hours, 7 days |
| Ankle Joint Function | Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days. | 24 and 72 hours, 7 days |
| Aventura |
| Florida |
| United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| Berlin | New Jersey | United States |
| Columbia | South Carolina | United States |
| El Paso | Texas | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Sodium Topical Gel 1% | |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 18 years and above | 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 | Pain on Movement | Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain" | Posted | Mean | Standard Deviation | mm | 72 hours |
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| Secondary | Pain on Movement | Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain" | Posted | Mean | Standard Deviation | mm | 24 hours and 7 days |
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| Secondary | Onset of Pain Relief | Onset of perceptible pain relief | Posted | Median | Inter-Quartile Range | Hour | Day 1 |
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| Secondary | Tenderness | Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness. | Posted | Mean | Standard Deviation | N/cm^2 | Change from baseline at 24 and 72 hours, 7 days |
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| Secondary | Ankle Joint Function | Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days. | Posted | Mean | Standard Deviation | Total score | 24 and 72 hours, 7 days |
|
|
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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 | Diclofenac Sodium Topical Gel 1% | 0 | 104 | 11 | 104 | |||
| EG001 | Placebo | 0 | 102 | 8 | 102 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous Sytem disorders | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Infection and infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Injury poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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Preliminary agreement between Novartis Consumer Health and the investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | Novartis Consumer Health | 0041223635528 |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Male |
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| 18 years and above |
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