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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Brasil Farmacêutica LTDA
• Collaborators: Daiichi Sankyo Co., Ltd.; Quintiles, Inc.
• Treatments: Loxoprofen

Criteria

Inclusion Criteria:

• For enrollment in this study, the eligible research subjects shall meet all criteria below:

• Sign and date the informed consent form;

• Age between 18 and 65 years old;

• Have recent (48 hours before study baseline visit) post-traumatic disease (contusion or sprain) of lower or upper limbs (except for fingers and toes), with at least one moderate or more serious symptom of pain or inflammation according to the investigator's evaluation.

Exclusion Criteria:

• Research subjects who meet any criteria below will not be eligible for the study:

• Have cardiovascular, renal, or hematological disease, diabetes mellitus, gastrointestinal disease, hepatic disease, asthma, rheumatoid arthritis, osteoarthritis, or any other serious chronic comorbidity (at the investigator's discretion);

• Prior history of gastrointestinal bleeding or ulcers (6 months before enrollment in the study);

• Have any hemorrhagic disorder;

• Have apparent complication of bacterial infection;

• Have a fracture or need of immobilization with cast or surgical procedure or neck sprain;

• Have a too small area affected (e.g., fingers) not allowing the use of the transdermal patch, skin sores in application site, bad or sensitive condition of the skin with prior history of dermatitis due to the use of topic drugs;

• Have made a prior (5 days before the study treatment is initiated) or current use of pain medications, NSAIDs, anti-inflammatory drugs, or steroids;

• Have a known allergy to loxoprofen, inactive ingredients of the formulation or any other NSAIDs;

• Subjects who are pregnant or breastfeeding or those who want to become pregnant or who refuse to use a safe birth control method during the study;

• Research subjects who have participated in another clinical study in the last 12 months.