Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Phase 3 Completed 428 enrolled Iroko Pharmaceuticals, LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.

Timeline

Start: 2011-10
Primary completion: 2012-02
Completion: 2012-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Diclofenac Test (Upper Dose) vs Placebo; p <0.001; Difference in Least Squares Mean 446.946 (95% CI 206.567 to 687.324); ANCOVA NCT01462435 ↗

registry analysis (superiority or other test); Diclofenac Test (Lower Dose) vs Placebo; p = 0.010; Difference in Least Squares Mean 316.145 (95% CI 77.136 to 555.155); ANCOVA NCT01462435 ↗

Publications

Argoff C, McCarberg B, Gudin J, Nalamachu S, Young C. SoluMatrix(R) Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain. Pain Med. 2016 Oct;17(10):1933-1941. doi: 10.1093/pm/pnw012. Epub 2016 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	200 mg	—
Subject	Diclofenac	Other / unclassified	18 mg	—
Subject	Diclofenac	Other / unclassified	35 mg	—

Indications

No indication recorded.