Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

Phase 3 Completed 277 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

Timeline

Start: 2007-07-25
Primary completion: 2008-10-14
Completion: 2008-10-14

Outcome

Met primary endpoint

registry analysis (superiority test); Diclofenac (DIC075V) vs Placebo; p <0.0001; ANCOVA NCT00507026 ↗

Publications

Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	—	Intravenous
Comparator	Ketorolac	Other / unclassified	—	Intravenous

Indications

No indication recorded.