CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Transdermal Patch +3 moredrug
Likely dose
Transdermal Patch 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02616068
NCT02616068Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double Blind, Non-inferiority, Comparative Study of the New Transdermal Patch Dosage Form Containing Loxoprofen Sodium (100 mg) and Loxonin® (60 mg Tablet) for the Treatment of Acute Traumatic Injuries

Daiichi Sankyo Brasil Farmacêutica LTDA·interventional·Posted Nov 26, 2015·Updated Feb 14, 2017

In Brief

A Phase 3 clinical trial evaluating Transdermal Patch, Loxoprofen sodium, and 2 other interventions for Trauma and Pain. Completed, enrolled 242 participants across 8 sites.

Detailed Summary

This study evaluates the non-inferiority of the new transdermal patch dosage form containing loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet - Daiichi-Sankyo) for the treatment of acute traumatic injuries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma, Pain
CountriesBrazil
CollaboratorsQuintiles, Inc., Daiichi Sankyo Co., Ltd.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 26, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.6 years ago

Interventions

Transdermal Patchdrug

Transdermal patch 100 mg once a day for 7 days

Loxoprofen sodiumdrug

Loxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days

Placebo (for loxoprofen sodium)drug

Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days

Placebo (for transdermal patch)drug

Placebo (for transdermal patch 100 mg) once a day for 7 days