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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Grade I/II Ankle Sprain |
| Interventions: |
Drug: diclofenac diethylamine gel 2.32% Drug: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | drug |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | drug |
| Placebo. Applied 3 Times a Day. | placebo |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | Placebo. Applied 3 Times a Day. | |
|---|---|---|---|
| STARTED | 80 | 80 | 82 |
| COMPLETED | 79 | 78 | 79 |
| NOT COMPLETED | 1 | 2 | 3 |
Baseline Characteristics
| Description | |
|---|---|
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | drug |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | drug |
| Placebo. Applied 3 Times a Day. | placebo |
| Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day | Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day | Placebo. Applied 3 Times a Day. | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
80 | 80 | 82 | 242 |
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Age
[units: participants] |
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| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 80 | 77 | 81 | 238 |
| >=65 years | 0 | 3 | 1 | 4 |
|
Age
[units: years] Mean ± Standard Deviation |
30.9 ± 11.4 | 32.2 ± 13.7 | 34.0 ± 12.9 | 32.4 ± 12.7 |
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Gender
[units: participants] |
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| Female | 31 | 31 | 28 | 90 |
| Male | 49 | 49 | 54 | 152 |
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Region of Enrollment
[units: participants] |
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| Germany | 80 | 80 | 82 | 242 |
Outcome Measures
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Novartis Consumer Health SA |
| ClinicalTrials.gov Identifier: | NCT00955513 History of Changes |
| Other Study ID Numbers: | VOPO-P-307 |
| Study First Received: | August 7, 2009 |
| Results First Received: | December 1, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices (BfArM) |