A Phase 4 interventional study of IODEX® balm and Placebo balm in Pain, sponsored by GlaxoSmithKline. Completed at 1 site in India. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-29.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Basic science
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.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
Drug: IODEX® balm
2 ± 0.2 g of product will be gently rubbed for 15 seconds on the affected knee joint.
Other: Placebo balm
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.
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.
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.
Time frame: Every minute from baseline to 10 minutes
Participants were recruited at one center in India.
| Milestone | First Test Balm Then Placebo Balm | First Placebo Balm Then Test Balm |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Milestone | First Test Balm Then Placebo Balm | First Placebo Balm Then Test Balm |
|---|---|---|
| Started | 8 | 6 |
| Completed | 8 | 6 |
| Not completed | 0 | 0 |
| Milestone | First Test Balm Then Placebo Balm | First Placebo Balm Then Test Balm |
|---|---|---|
| Started | 8 | 6 |
| Completed | 8 | 6 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Collected over From application of investigational product upto 5 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Balm | — | 0/8 (0%) | 0/8 (0%) |
| Placebo Balm | — | 0/7 (0%) | 0/7 (0%) |
Baseline measures is presenting the data of Intent to treat (ITT) population.
| Age, Continuous(Years) | Overall Participants |
|---|---|
| Mean | 49.9 ± 8.0 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 10 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Overall Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 14 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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