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The rationale of this study is to map out changes in temperature distribution brought about by topical application of our test product, and use this physiological phenomenon to visualize the onset of action involved in overall mechanism of action of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | 2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint. |
|
| Placebo | Placebo Comparator | 2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IODEX® balm | Drug | 2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Significant Increase in Local Surface Temperature | Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant. | Every minute from baseline to 10 minutes |
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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 |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Indiranagar, Banglador | 560038 | India |
Of the 19 participants screened, 15 were randomized, 14 completed the study.
Participants were recruited at one center in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Test Balm Then Placebo Balm | 2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package . |
| FG001 | First Placebo Balm Then Test Balm | 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package . |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (D0) |
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| Washout Period |
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| Period 2 (D3) |
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Baseline measures is presenting the data of Intent to treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Total number of participants randomized and treated in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Significant Increase in Local Surface Temperature | Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant. | Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero. | Posted | Every minute from baseline to 10 minutes |
From application of investigational product upto 5 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 | Test Balm | 2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint. |
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Primary outcome measure was to detect significant increase in surface temperature. Since this was not observed for either treatment, there was no statistical analysis comparing the two arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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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| Placebo balm | Other | 2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Test Balm | 2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint. |
| OG001 | Placebo Balm | 2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint. |
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo Balm | 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint. | 0 | 7 | 0 | 7 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.