Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Diclofenac diethylamine 2.32% gel
Diclofenac diethylamine 2.32% · 1 trial · 1 indication
The investigator performed a movement of the ankle and the pain assessment was done by the participant using a 100 mm VAS by describing ankle pain on movement. The POM was registered by the participant by drawing a perpendicular line on the 100 mm VAS with anchors at 0 = no pain and 100 = extreme pain. Higher scores indicate a worse outcome. Change from Baseline in POM was calculated by subtracting the Baseline value from the Day 5 value.
| Arm | Type | Description |
|---|---|---|
| Diclofenac diethylamine (DDEA) 2.32%/ Placebo gel | EXPERIMENTAL | Participants will receive 4 tubes, DDEA 2.32% gel and Placebo gel (2 each) and instructed to apply the gel 5 centimeter (cm) topically with the finger tips (for approximately 1 minute) on both sides of affected ankle on area of approximately 200 square centimeters (cm\^2). DDEA 2.32% gel will be applied in morning and late afternoon and Placebo gel will be applied in noon and late evening for 7 days. |
| DDEA 1.16% gel | ACTIVE_COMPARATOR | Participants will receive 4 tubes of DDEA 1.16% gel and instructed to apply the gel 5 centimeter (cm) topically with the finger tips (for approximately 1 minute) on both sides of affected ankle on area of approximately 200 square centimeters (cm\^2) in morning, noon, late afternoon, and late evening for 7 days. |
| Name | Type | Description |
|---|---|---|
| Diclofenac diethylamine 2.32% gel | DRUG | Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days. |
| Diclofenac diethylamine 1.16% gel | DRUG | Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 four times daily for 7 days. |
| Placebo | OTHER | Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days. |
Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment will be performed. * A participant who is willing and able to comply with scheduled visits, treat...