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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 DOMS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac sodium gel 1% | Experimental | diclofenac sodium gel 1% applied four times daily |
|
| Placebo | Placebo Comparator | Placebo gel applied four times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium gel 1% | Drug | Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over). |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. | 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 modified ITT population. SPID 24 derived from Pain on Walking (POW) 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. | Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome. Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, 100 W California Blvd, | Pasadena | California | 91105 | United States |
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Study Start 7 Oct 2014 and End 24 dec 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Sodium Gel 1% and Placebo Gel | This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over). |
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| 48 hours |
| COMPLETED |
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| NOT COMPLETED |
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ITT population: All randomized subjects who received at least one dose of the study drug on both legs = 102 Modified ITT population: Excludes the first 16 subjects who were systematically underdosed =86 Safety population: All randomized subjects who received at least one dose of study drug on either leg =102
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Sodium Gel 1% | diclofenac sodium gel 1% applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. | 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 modified ITT population. SPID 24 derived from Pain on Walking (POW) 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. | Posted | Mean | Standard Deviation | units on a scale (NRS) | 24 hours |
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| Secondary | Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. | Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome. Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 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. | Posted | Mean | Standard Deviation | units on a scale (NRS) | 48 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 Gel 1% | diclofenac sodium gel 1% applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily | 0 | 102 | 0 | 102 |
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Preliminary agreement between Novartis Consumer Health and the investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research pain category | Novartis Consumer Health a GSK Consumer Healthcare company | +413635528 |
| ID | Term |
|---|---|
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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