Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma
Condition: Trauma; Pain
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The primary objective of the study will be to verify the efficacy of loxoprofen in its new
      dosage form for the treatment of pain.

      Primary endpoint: score of change in spontaneous pain by using the visual analogue scale
      (VAS) after seven days of treatment.

      Secondary endpoints: intensity of pain evaluated by the VAS scale on each study visit,
      impression of the research subject checked by a 7-point scale, changes in clinical symptoms,
      and frequency of use of the rescue medication. Evaluation of drug safety as per the
      occurrence of adverse events and serious adverse events.

      This is a double blind, randomized, comparative study, with a total of 208 subjects divided
      into 2 groups: 104 subjects treated with loxoprofen sodium (transdermal patch 100 mg;
      Daiichi-Sankyo) associated with placebo tablet (experimental group) and 104 subjects treated
      with transdermal patch of placebo associated with Loxonin® (loxoprofen sodium 60 mg -
      Daiichi-Sankyo - control group).

      In order to be enrolled in the study, the research subject shall sign and date the informed
      consent form and shall have between 18 and 65 years old, with recent (48 hours before study
      baseline visit) posttraumatic 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, with no prior (5 days before
      initiating the study treatment) or current use of pain medication, NSAIDs, anti-inflammatory
      drugs, or steroids. In addition, research subjects shall not experience cardiovascular,
      renal, or hematological diseases, diabetes mellitus, psychiatric disorders, or any other
      serious comorbidity (at the investigator's discretion), apparent complication of a bacterial
      infection, fracture or requiring immobilization with cast or surgical procedure, neck sprain,
      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, prior history of gastrointestinal bleeding or
      ulcers, bronchial asthma of any cause, allergy to loxoprofen or any other NSAIDs. Also, the
      subjects should not have participated in any other clinical study in the last 12 months and
      pregnant or breastfeeding subjects or those who want to become pregnant or who refuse to use
      a safe birth control method during the study will not be enrolled in the study.

      The accrual period anticipated for the study will be of 4 to 5 months as of the regulatory
      approval of the protocol. Total duration of participation of each research subject and active
      treatment will be of 1 week.
    

Intervention name(s): Transdermal Patch; Loxoprofen sodium; Placebo (for loxoprofen sodium); Placebo (for transdermal patch)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Transdermal patch 100 mg once a day for 7 days; Loxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days; Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days; Placebo (for transdermal patch 100 mg) once a day for 7 days
Intervention MeSH terms: Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment