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This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac sodium gel 1% | Experimental | diclofenac sodium gel 1% |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug |
| ||
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Site | Bradenton | Florida | United States | |||
| US Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Sodium Gel 1% | diclofenac sodium gel 1% diclofenac sodium gel 1% |
| FG001 | Placebo | Placebo diclofenac sodium gel 1% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Port Orange |
| Florida |
| United States |
| US Site | Boise | Idaho | United States |
| US Site | Grand Rapids | Michigan | United States |
| US Site | Omaha | Nebraska | United States |
| US Site | Brooklyn | New York | United States |
| US Site | Columbus | Ohio | United States |
| US Site | State College | Pennsylvania | United States |
| US Site | Bellaine | Texas | United States |
| US Site | Houston | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Sodium Gel 1% | diclofenac sodium gel 1% diclofenac sodium gel 1% |
| BG001 | Placebo | Placebo diclofenac sodium gel 1% |
| 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 | Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
7 days
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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 Gel 1% | diclofenac sodium gel 1% diclofenac sodium gel 1% | 0 | 109 | 4 | 109 | ||
| EG001 | Placebo | Placebo diclofenac sodium gel 1% | 0 | 106 | 2 | 106 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA 10.0) | Systematic Assessment |
|
Preliminary agreement between Novartis Consumer Health and the investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director Pain, CH Clinical Research & Development Lead | Novartis Consumer Health | +41225672574 |
| ID | Term |
|---|---|
| D003288 | Contusions |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
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| Male |
|