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This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac diethylamine 2.32% gel | Drug | Diclofenac diethylamine 2.32% gel twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain) | change from baseline (on day 1) to day 5 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Axel Baltzer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bad Bramstedt | 24576 | Germany | |||
| Novartis Investigative Site |
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Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Diethylamine (DDEA) 2.32% Gel BID | Twice daily (BID) application |
| FG001 | DDEA 2.32% Gel OD | Once daily (OD) application of active gel and OD application of vehicle gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Vehicle 2 times daily |
|
| Diclofenac diethylamine 2.32% gel / Placebo | Drug | Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily |
|
| Bad Nauheim |
| 61231 |
| Germany |
| Novartis Investigative Site | Bad Zwischenahn | 26160 | Germany |
| Novartis Investigative Site | Berlin | 10589 | Germany |
| Novartis Investigative Site | Berlin | 10961 | Germany |
| Novartis Investigative Site | Berlin | 12247 | Germany |
| Novartis Investigative Site | Berlin | 12349 | Germany |
| Novartis Investigative Site | Berlin | 14163 | Germany |
| Novartis Investigative Site | Berlin | 14169 | Germany |
| Novartis Investigative Site | Bochum | 44789 | Germany |
| Novartis Investigative Site | Dortmund | 44263 | Germany |
| Novartis Investigative Site | Dresden | 01129 | Germany |
| Novartis Investigative Site | Düsseldorf | 40212 | Germany |
| Novartis Investigative Site | Eichstätt | 85072 | Germany |
| Novartis Investigative Site | Hamburg | 20357 | Germany |
| Novartis Investigative Site | Hamburg | 22143 | Germany |
| Novartis Investigative Site | Hammelburg | 97762 | Germany |
| Novartis Investigative Site | Karlsruhe | 76133 | Germany |
| Novartis Investigative Site | Kaufbeuren | 87600 | Germany |
| Novartis Investigative Site | Lambrecht/Pfalz | 67466 | Germany |
| Novartis Investigative Site | Leipzig | 04109 | Germany |
| Novartis Investigative Site | Meersburg | 88709 | Germany |
| Novartis Investigative Site | Munich | 80339 | Germany |
| Novartis Investigative Site | München | 80333 | Germany |
| Novartis Investigative Site | München | 80538 | Germany |
| Novartis Investigative Site | München | 80798 | Germany |
| Novartis Investigative Site | Neustadt/Aisch | 91413 | Germany |
| Novartis Investigative Site | Siegen | 57074 | Germany |
| Novartis Investigative Site | Stockach | 78333 | Germany |
| FG002 | Vehicle Gel | BID application |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Diethylamine (DDEA) 2.32% Gel BID | Twice daily (BID) application |
| BG001 | DDEA 2.32% Gel OD | Once daily (OD) application of active gel and OD application of vehicle gel |
| BG002 | Vehicle Gel | BID application |
| 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 Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain) | Intent to treat (ITT) | Posted | Mean | Standard Deviation | mm | change from baseline (on day 1) to 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 (DDEA) 2.32% Gel BID | Twice daily (BID) application | 0 | 89 | 3 | 89 | ||
| EG001 | DDEA 2.32% Gel OD | Once daily (OD) application of active gel and OD application of vehicle gel | 0 | 91 | 6 | 91 | ||
| EG002 | Vehicle Gel | BID application | 0 | 91 | 1 | 91 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDra 10.1 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandy Hamelsky | Novartis Consumer Health | +19735037258 | sandy.hamelsky@novartis.com |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000614065 | diclofenac diethylamine |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
|