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The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac diethylamine gel 2.32% gel twice a day | Experimental | drug |
|
| diclofenac diethylamine gel 2.32% gel three times a day | Experimental | drug |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac diethylamine gel 2.32% | Drug | diclofenac diethylamine gel 2.32% twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Pain on Movement on Day 5 (Change From Baseline). | Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome. | baseline and day 5 |
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Inclusion Criteria:
1. Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cologne | Germany | ||||
| Novartis Investigative Site |
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6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | drug |
| FG001 | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | drug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| diclofenac diethylamine gel 2.32% | Drug | diclofenac diethylamine gel 2.32% three times a day |
|
| Placebo | Drug | Placebo |
|
| Essen |
| Germany |
| Novartis Investigative Site | Gilching | Germany |
| Novartis Investigative Site | Grünwald | Germany |
| Novartis Investigative Site | München | Germany |
| FG002 | Placebo. Applied 3 Times a Day. | placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | drug |
| BG001 | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | drug |
| BG002 | Placebo. Applied 3 Times a Day. | placebo |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Measure: Pain on Movement on Day 5 (Change From Baseline). | Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome. | Posted | Mean | Standard Deviation | mm | baseline and day 5 |
|
|
|
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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 Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | drug | 0 | 80 | 0 | 80 | ||
| EG001 | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | drug | 0 | 80 | 1 | 80 | ||
| EG002 | Placebo. Applied 3 Times a Day. | placebo | 0 | 82 | 1 | 82 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader Pain category | Novartis Consumer Health | +41223635528 |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|