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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 ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Diclofenac sodium topical gel 1% | Experimental | Diclofenac sodium topical gel 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium | Drug | 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 |
|---|---|---|
| Onset of Pain Relief | Onset of perceptible pain relief. | On day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH investigative site | Bad Nauheim | Germany | ||||
| NCH investigative site |
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Study Start 18 January 2011 Study end 23 August 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily |
| FG001 | Placebo | Placebo : Topical gel-4 times daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily |
| BG001 | Placebo | Placebo : Topical gel-4 times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age : 18 years and over |
| 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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| 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% | Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distorsion of wrist and ligament rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | Novartis Consumer Health | 0041223635228 |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| 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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| Placebo |
| Other |
Topical gel-4 times daily |
|
| Brühl |
| Germany |
| NCH investigative site | Cologne | Germany |
| NCH investigative site | Essen | Germany |
| NCH investigative site | Gilching | Germany |
| NCH investigative site, Munich, Germany. | Munich | Germany |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Onset of Pain Relief | Onset of perceptible pain relief. | Posted | Median | Inter-Quartile Range | Hours | On day 1 |
|
|
|
| 0 |
| 102 |
| 6 |
| 102 |
| EG001 | Placebo | Placebo : Topical gel-4 times daily | 1 | 103 | 3 | 103 |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
Preliminary agreement between Novartis Consumer Health and the investigator