Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01055262 | Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back | PHASE3 | COMPLETED | 169 | — | — | Jan 1, 2010 | Feb 1, 2010 | Jun 19, 2012 | - | — |
Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter \[cm\] diameter), bullae (\> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
| Arm | Type | Description |
|---|---|---|
| Heatwrap 1 | EXPERIMENTAL | Experimental heatwrap device for the lower back |
| Name | Type | Description |
|---|---|---|
| Heatwrap 1 | DEVICE | 8 hours continuous topically-applied heat |
Inclusion Criteria: * The subject is a male or female in generally good health greater or equal to 35 years of age; * Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transderma...