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

NCT02616068 | Completed Phase 3

• 1 other identifier: CS600-A-L301 - Loxonin Tape
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 8

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.

Conditions

Trauma; Pain

Outcome Measures

Primary Outcomes (1)

• Score of change in spontaneous pain by using the visual analogue scale (VAS)

  after seven days of treatment.

Secondary Outcomes (3)

• 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

Study Arms (2)

transdermal patch & placebo

EXPERIMENTAL

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

Drug: Transdermal Patch; Drug: Placebo (for loxoprofen sodium)

loxoprofen sodium & placebo

ACTIVE COMPARATOR

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

Drug: Loxoprofen sodium; Drug: Placebo (for transdermal patch)

Interventions

Transdermal Patch DRUG

Transdermal patch 100 mg once a day for 7 days

transdermal patch & placebo

Loxoprofen sodium DRUG

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

loxoprofen sodium & placebo

Placebo (for loxoprofen sodium) DRUG

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

transdermal patch & placebo

Placebo (for transdermal patch) DRUG

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

loxoprofen sodium & placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Brasil Farmacêutica LTDA: lead
• Quintiles, Inc.: collaborator
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (8)

Ctd Clinica de Terapia Da Dor Ltda

Salvador, Estado de Bahia, 40170-150, Brazil

Location

Med Centro de Estudos- Crd- Centro

Goiânia, Goiás, 74020-010, Brazil

Location

CMiP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

HMCG - Hospital e Maternidade Dr. Christovão da Gama

Santo André, São Paulo, 09030-010, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Hospital Nipo-Brasileiro

São Paulo, São Paulo, 02189-010, Brazil

Location

Related Publications (11)

• Dreiser RL. Topical antirheumatic drug therapy: current practice and future trends. Eur J Rheumatol Inflamm. 1994;14(4):3-8. No abstract available.

  PMID: 7601180 BACKGROUND

• Garrett WE Jr. Muscle strain injuries: clinical and basic aspects. Med Sci Sports Exerc. 1990 Aug;22(4):436-43.

  PMID: 2205779 RESULT

• Liu SH, Nguyen TM. Ankle sprains and other soft tissue injuries. Curr Opin Rheumatol. 1999 Mar;11(2):132-7. doi: 10.1097/00002281-199903000-00009.

  PMID: 10319217 RESULT

• Almekinders LC. Anti-inflammatory treatment of muscular injuries in sport. An update of recent studies. Sports Med. 1999 Dec;28(6):383-8. doi: 10.2165/00007256-199928060-00001.

  PMID: 10623981 RESULT

• Jarvinen TA, Jarvinen TL, Kaariainen M, Kalimo H, Jarvinen M. Muscle injuries: biology and treatment. Am J Sports Med. 2005 May;33(5):745-64. doi: 10.1177/0363546505274714.

  PMID: 15851777 RESULT

• Garrett WE Jr, Nikolaou PK, Ribbeck BM, Glisson RR, Seaber AV. The effect of muscle architecture on the biomechanical failure properties of skeletal muscle under passive extension. Am J Sports Med. 1988 Jan-Feb;16(1):7-12. doi: 10.1177/036354658801600102.

  PMID: 3344884 RESULT

• Garrett WE Jr, Safran MR, Seaber AV, Glisson RR, Ribbeck BM. Biomechanical comparison of stimulated and nonstimulated skeletal muscle pulled to failure. Am J Sports Med. 1987 Sep-Oct;15(5):448-54. doi: 10.1177/036354658701500504.

  PMID: 3674268 RESULT

• Arrington ED, Miller MD. Skeletal muscle injuries. Orthop Clin North Am. 1995 Jul;26(3):411-22.

  PMID: 7609956 RESULT

• Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

  PMID: 3461421 RESULT

• Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.

  PMID: 10376632 RESULT

• Stanos SP. Topical agents for the management of musculoskeletal pain. J Pain Symptom Manage. 2007 Mar;33(3):342-55. doi: 10.1016/j.jpainsymman.2006.11.005.

  PMID: 17349504 RESULT

MeSH Terms

Conditions

Wounds and Injuries; Pain

Interventions

Transdermal Patch; loxoprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

BR (8)