Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma
- Conditions
- TraumaPain
- Interventions
- Drug: Transdermal PatchDrug: Placebo (for loxoprofen sodium)Drug: Placebo (for transdermal patch)
- Registration Number
- NCT02616068
- Lead Sponsor
- Daiichi Sankyo Brasil Farmacêutica LTDA
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description transdermal patch & placebo Transdermal Patch transdermal patch 100 mg once a day for 7 days and placebo (for loxoprofen sodium 60 mg tablet) by mouth, every 8 hours for 7 days transdermal patch & placebo Placebo (for loxoprofen sodium) transdermal patch 100 mg once a day for 7 days and placebo (for loxoprofen sodium 60 mg tablet) by mouth, every 8 hours for 7 days loxoprofen sodium & placebo Loxoprofen sodium loxoprofen sodium 60 mg by mouth, every 8 hours for 7 days and placebo (for transdermal patch 100 mg) once a day for 7 days loxoprofen sodium & placebo Placebo (for transdermal patch) loxoprofen sodium 60 mg by mouth, every 8 hours for 7 days and placebo (for transdermal patch 100 mg) once a day for 7 days
- Primary Outcome Measures
Name Time Method Score of change in spontaneous pain by using the visual analogue scale (VAS) after seven days of treatment.
- Secondary Outcome Measures
Name Time Method Intensity of pain evaluated by the VAS scale on day 3 and on day 7 Impression of the research subject checked by a 7-point scale on day 3 and on day 7 Evaluation of drug safety as per the occurrence of adverse events and serious adverse events. on day 3 and on day 7, for SAE up to 30 days
Trial Locations
- Locations (8)
Ctd Clinica de Terapia Da Dor Ltda
🇧🇷Salvador, Bahia, Brazil
Med Centro de Estudos- Crd- Centro
🇧🇷Goiania, Goias, Brazil
CMiP - Centro Mineiro de Pesquisa
🇧🇷Juiz de Fora, Minas Gerais, Brazil
HMCG - Hospital e Maternidade Dr. Christovão da Gama
🇧🇷Santo Andre, Sao Paulo, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
Hospital Nipo-Brasileiro
🇧🇷São Paulo, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Sao Paulo, Brazil