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The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac sodium topical gel 1% | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium | Drug | Topical gel 1%- 4 times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on Movement | Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain" | VAS Score at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Pain Relief | Onset of perceptible pain relief. | From randomization to end of day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH investigative site | Brühl | Germany | ||||
| NCH investigative site |
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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 |
| Other |
Topical gel - 4 times daily |
|
| Butzbach |
| Germany |
| NCH investigative site | Cologne | Germany |
| NCH investigative site | Essen | Germany |
| NCH investigative site | Gilching | Germany |
| NCH investigative site | Munich | Germany |
| COMPLETED |
|
| 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 |
|
| 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 |
| ||||||||||||||||
| 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 | Pain on Movement | Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain" | Posted | Mean | Standard Deviation | mm | VAS Score at 24 hours |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Onset of Pain Relief | Onset of perceptible pain relief. | Posted | Median | Inter-Quartile Range | Hours | From randomization to end of day 1 |
|
|
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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 | 2 | 104 | |||
| EG001 | Placebo | 0 | 100 | 4 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and Infestations | Infections and infestations | MedDra 10.0 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDra 10.0 | Systematic Assessment |
|
Preliminary agreement between Novartis Consumer Health and the Principal Investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | Novartis Consumer Health S.A. | +41 22 3635528 |
| ID | Term |
|---|---|
| D003288 | Contusions |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Male |
|
|