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 Sodium Gel, Diclofenac Sodium, diclofenac-K
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...
Diclofenac is a small molecule drug studied for musculoskeletal and inflammatory conditions, including acute ankle sprain, ankle sprain, acute blunt soft tissue injuries and contusions, muscle soreness, and inflammation. It has also been studied in advanced solid tumors, excluding breast cancer. It is being developed by Novartis AG.
Diclofenac targets PTGS2 and PTGS1. It is classified as an inhibitor of these targets, which are cyclooxygenase enzymes. This target profile underlies its investigation in inflammatory and musculoskeletal conditions as well as in advanced solid tumors excluding breast cancer.
Diclofenac is developed by Novartis AG, which trades under the ticker NVS. The drug is a small molecule in the musculoskeletal therapeutic area. It is also marketed under several alternative names, including Diclofenac Sodium, Diclofenac Potassium, and Diclofenac Sodium Gel.
Diclofenac is in Phase 3 development. It is investigational and is not stated to be FDA approved for the indications studied. Four clinical trials have been completed, with no active trials currently listed, and total enrollment across those completed trials was 1,650 participants.
Completed diclofenac trials include NCT02476422 in postoperative dental pain, NCT02271854 in delayed onset muscle soreness, NCT01272947 in acute blunt trauma injuries, and NCT01596647 in advanced solid tumors excluding breast cancer. All four were randomized, double-blind, and placebo-controlled, with enrollment totaling 1,650 participants.
Yes. Diclofenac is also known as Diclofenac Sodium, Diclofenac Potassium, Diclofenac Sodium Gel, Diclofenac Topical Sodium Gel 1%, Diclofenac 1%, and Diclofenac Sodium 50 mg Tablets, among other names. These refer to the same active drug in different salt or formulation forms.