Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Diclofenac Topical Sodium Gel 1%, Diclofenac 1%, Diclofenac sodium topical gel 1%, Diclofenac sodium gel 1%, Diclofenac potassium, Diclofenac topical sodium gel 1%, Diclofenac Sodium Gel, Diclofenac Sodium
diclofenac · 14 trials · 11 indications
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.
Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
| Arm | Type | Description |
|---|---|---|
| Dilcofenac potassium + placebo to Ibuprofen | EXPERIMENTAL | Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method. |
| Ibuprofen + placebo to diclofenac potassium | ACTIVE_COMPARATOR | Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method. |
| diclofenac sodium gel 1% | EXPERIMENTAL | diclofenac sodium gel 1% applied four times daily |
| Placebo | PLACEBO_COMPARATOR | Placebo gel applied four times daily |
| Diclofenac sodium topical gel 1% | EXPERIMENTAL | Diclofenac sodium topical gel 1% |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| TKI258 (dovitinib) | EXPERIMENTAL | dovitinib, 5 days on / 2 days off dose schedule |
| Name | Type | Description |
|---|---|---|
| Diclofenac potassium | DRUG | Single dose of diclofenac 50 mg soft gelatin capsule |
| Ibuprofen | DRUG | Single dose of ibuprofen 400 mg tablet |
| Placebo to ibuprofen | DRUG | Single dose of placebo to ibuprofen 400 mg tablet |
| Placebo to diclofenac potassium | DRUG | Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule |
| Diclofenac sodium gel 1% | DRUG | Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over). |
| Placebo | DRUG | Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over). |
| Diclofenac Sodium | DRUG | Topical gel 1%-4 times daily |
| Diclofenac sodium topical gel 1% | DRUG | Diclofenac sodium topical gel 1%, 4 times daily |
| Diclofenac Sodium Gel | DRUG | 4 grams per knee, 4 times per day, for 12 weeks |
| Diclofenac sodium 1mg/g | DRUG | - |
| Diclofenac topical sodium gel 1% | DRUG | - |
| caffeine | DRUG | single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam |
| diclofenac | DRUG | single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam |
| omeprazole | DRUG | single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam |
| midazolam | DRUG | single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam |
| TKI258 | DRUG | dovitinib, 5 days on / 2 days off dose schedule |
| Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc) | DRUG | - |
| Voltaren 50 mg Tablets (Geigy Pharmaceuticals) | DRUG | - |
Key Inclusion Criteria: * Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level. * Patients having a moderate to severe Baseline pain intensity as assessed b...