TraumaPhase 3NCT02616068
Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma
A Phase 3 study testing Transdermal Patch and Loxoprofen sodium in people with Trauma and Pain, run by Daiichi Sankyo Brasil Farmacêutica LTDA at 8 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Transdermal Patch and Loxoprofen sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 8 sitesBrazil
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Med Centro de Estudos- Crd- Centro
Goiânia, Goiás, 74020-010
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Ctd Clinica de Terapia Da Dor Ltda
Salvador, Estado de Bahia, 40170-150
HMCG - Hospital e Maternidade Dr. Christovão da Gama
Santo André, São Paulo, 09030-010
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Hospital Nipo-Brasileiro
São Paulo, São Paulo, 02189-010
About this study
Official title: A Phase III, Randomized, Double Blind, Non-inferiority, Comparative Study of the New Transdermal Patch Dosage Form Containing Loxoprofen Sodium (100 mg) and Loxonin® (60 mg Tablet) for the Treatment of Acute Traumatic Injuries
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.
Read the 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.
- Being tested
- Transdermal Patch, Loxoprofen sodium, Placebo (for loxoprofen sodium), Placebo (for transdermal patch)
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal PatchDrug
Transdermal patch 100 mg once a day for 7 days
Loxoprofen sodiumDrug
Loxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days
Placebo (for loxoprofen sodium)Drug
Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days
Placebo (for transdermal patch)Drug
Placebo (for transdermal patch 100 mg) once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Loxoprofen sodium; Drug: Placebo (for transdermal patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of change in spontaneous pain by using the visual analogue scale (VAS)
Measured: after seven days of treatment.
Secondary outcomes (3)
Intensity of pain evaluated by the VAS scale
Measured: on day 3 and on day 7
Impression of the research subject checked by a 7-point scale
Measured: on day 3 and on day 7
Evaluation of drug safety as per the occurrence of adverse events and serious adverse events.
Measured: on day 3 and on day 7, for SAE up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Brasil Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616068
- Sponsor's protocol ID
- CS600-A-L301 - Loxonin Tape
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dreiser RL. Topical antirheumatic drug therapy: current practice and future trends. Eur J Rheumatol Inflamm. 1994;14(4):3-8. No abstract available.
PubMed 7601180Garrett WE Jr. Muscle strain injuries: clinical and basic aspects. Med Sci Sports Exerc. 1990 Aug;22(4):436-43.
PubMed 2205779Liu 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.
PubMed 10319217Almekinders 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.
PubMed 10623981Jarvinen 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.
PubMed 15851777Garrett 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.
PubMed 3344884Garrett 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.
PubMed 3674268Arrington ED, Miller MD. Skeletal muscle injuries. Orthop Clin North Am. 1995 Jul;26(3):411-22.
PubMed 7609956Classification 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.
PubMed 3461421Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.
PubMed 10376632Stanos 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.
PubMed 17349504
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double Blind, Non-inferiority, Comparative Study of the New Transdermal Patch Dosage Form Containing Loxoprofen Sodium (100 mg) and Loxonin® (60 mg Tablet) for the Treatment of Acute Traumatic Injuries
- ClinicalTrials.gov ID
- NCT02616068
- Acronym / sponsor ID
- CS600-A-L301 - Loxonin Tape
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Daiichi Sankyo Brasil Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc., Daiichi Sankyo Co., Ltd.
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transdermal patch & placebo | Experimental | Drug: Transdermal Patch, Drug: 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 | Active comparator | Drug: Loxoprofen sodium, Drug: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For enrollment in this study, the eligible research subjects shall meet all criteria below:
Key exclusion criteria (11 listed)
- Research subjects who meet any criteria below will not be eligible for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal PatchTransdermal patch 100 mg once a day for 7 days | Drug | transdermal patch & placebo |
| Loxoprofen sodiumLoxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days | Drug | loxoprofen sodium & placebo |
| Placebo (for loxoprofen sodium)Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days | Drug | transdermal patch & placebo |
| Placebo (for transdermal patch)Placebo (for transdermal patch 100 mg) once a day for 7 days | Drug | loxoprofen sodium & placebo |
Primary outcome
Score of change in spontaneous pain by using the visual analogue scale (VAS)
Time frame: after seven days of treatment.
3 secondary outcomes
Intensity of pain evaluated by the VAS scale
Time frame: on day 3 and on day 7
Impression of the research subject checked by a 7-point scale
Time frame: on day 3 and on day 7
Evaluation of drug safety as per the occurrence of adverse events and serious adverse events.
Time frame: on day 3 and on day 7, for SAE up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background: PubMed 7601180Dreiser RL. Topical antirheumatic drug therapy: current practice and future trends. Eur J Rheumatol Inflamm. 1994;14(4):3-8. No abstract available.
- Results publication: PubMed 2205779Garrett WE Jr. Muscle strain injuries: clinical and basic aspects. Med Sci Sports Exerc. 1990 Aug;22(4):436-43.
- Results publication: PubMed 10319217Liu 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.
- Results publication: PubMed 10623981Almekinders 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.
- Results publication: PubMed 15851777Jarvinen 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.
- Results publication: PubMed 3344884Garrett 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.
- Results publication: PubMed 3674268Garrett 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.
- Results publication: PubMed 7609956Arrington ED, Miller MD. Skeletal muscle injuries. Orthop Clin North Am. 1995 Jul;26(3):411-22.
- Results publication: PubMed 3461421Classification 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.
- Results publication: PubMed 10376632Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.
- Results publication: PubMed 17349504Stanos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transdermal Patch and Loxoprofen sodium in people with Trauma and Pain, run by Daiichi Sankyo Brasil Farmacêutica LTDA at 8 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of change in spontaneous pain by using the visual analogue scale (VAS) (time frame: after seven days of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616068, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.