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| ID | Type | Description | Link |
|---|---|---|---|
| RH02170 | Other Identifier | GSK |
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This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.
Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.
The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.
During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Sodium/Menthol Gel | Experimental | 1% diclofenac sodium + 3% menthol |
|
| Diclofenac Gel | Active Comparator | 1% diclofenac sodium + 0.09% menthol |
|
| Menthol Gel | Active Comparator | 3% menthol |
|
| Placebo Gel | Placebo Comparator | 0.09% menthol |
|
| Voltaren Gel | Active Comparator | 1% diclofenac sodium |
|
| Sodium lauryl sulfate | Placebo Comparator | 0.2% Sodium lauryl sulfate |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Diclofenac Sodium | Drug | 1% diclofenac sodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment mean cumulative irritation score | Cumulative irritation scores will be defined daily as the sum of irritation score and grade number | Day 21 |
| Adverse event assessment | Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities | 21 days + 5 days follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research Inc | Paramus | New Jersey | 07652 | United States |
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| Label | URL |
|---|---|
| Results for the study 202187 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D008610 | Menthol |
| D012967 | Sodium Dodecyl Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline | Placebo Comparator | 0.9% saline |
|
| 3% Menthol | Drug | 3% Menthol |
|
| 0.09% Menthol | Drug | 0.09% Menthol |
|
| 0.2% Sodium Lauryl Sulfate | Drug | 0.2% Sodium Lauryl Sulfate |
|
| 0.9% Saline | Drug | 0.9% Saline |
|
| D003511 |
| Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
| D007851 | Dodecanol |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |