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Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma

NCT02616068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2017-02-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Transdermal Patch

Transdermal patch 100 mg once a day for 7 days

DRUG

Loxoprofen sodium

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

DRUG

Placebo (for loxoprofen sodium)

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

DRUG

Placebo (for transdermal patch)

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

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Daiichi Sankyo Brasil Farmacêutica LTDA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616068 on ClinicalTrials.gov