Delayed Onset Muscle SorenessPhase 2NCT02602353
Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
A Phase 2 study testing Loxoprofen Pain Patch and No Treatment in people with Delayed Onset Muscle Soreness, run by Lead Chemical Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Loxoprofen Pain Patch and No Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2015
- Phase
- Phase 2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, 18 to 40 years of age
- are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
- develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale
Who cannot join
- has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
- has been working heavy manual or physical labor jobs within 3 months prior to study participation.
- has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
- has skin lesions such as psoriasis at the application site
- has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
- has an allergy-related skin condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)
The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Loxoprofen Pain Patch, Placebo Patch, No Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loxoprofen Pain PatchDrug
One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo PatchDrug
One Placebo Patch applied daily for 3 days
No TreatmentDrug
No Treatment for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Loxoprofen Pain Patch | Experimental | One Active Pain Patch containing loxoprofen applied once daily for 3 days Receives: Drug: Loxoprofen Pain Patch |
| Placebo Patch | Placebo comparator | One Placebo Patch applied once daily for 3 days Receives: Drug: Placebo Patch |
| No Treatment | Other | No Treatment for 3 days Receives: Drug: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
Measured: 0-24 hours
Secondary outcomes (6)
Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest
Measured: 0-24 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement
Measured: 0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest
Measured: 0-48 hours
Time to onset of first perceptible pain relief
Measured: First 4 hours after Dose 1
Time to onset of meaningful pain relief
Measured: First 4 hours after Dose 1
Subjects global impression of medication
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle SorenessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lead Chemical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardinal Health
- Responsible party
- Sponsor
- Investigators
- Derek Muse, MD, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602353
- Sponsor's protocol ID
- LEAD-PhII-050
- Status last verified
- Oct 2016
- First submitted
- 9 Nov 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Parallel-Group and Placebo-Controlled Pilot Study to Assess the Safety and Efficacy of a New Pain Patch Versus Placebo and No Treatment for the Treatment of Delayed Onset Muscle Soreness (DOMS)
- ClinicalTrials.gov ID
- NCT02602353
- Acronym / sponsor ID
- LEAD-PhII-050
- Conditions
- Delayed Onset Muscle Soreness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lead Chemical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cardinal Health
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 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.
The purpose of this study is to evaluate the analgesic efficacy and safety of a new pain patch compared to placebo and no treatment in subjects experiencing Delayed Onset Muscle Soreness (DOMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Loxoprofen Pain Patch | Experimental | Drug: Loxoprofen Pain PatchOne Active Pain Patch containing loxoprofen applied once daily for 3 days |
| Placebo Patch | Placebo comparator | Drug: Placebo PatchOne Placebo Patch applied once daily for 3 days |
| No Treatment | Other | Drug: No TreatmentNo Treatment for 3 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females, 18 to 40 years of age
- are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
- develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale
Key exclusion criteria (6 listed)
- has engaged in upper extremity exercise for a minimum of 6 months prior to study participation
- has been working heavy manual or physical labor jobs within 3 months prior to study participation.
- has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
- has skin lesions such as psoriasis at the application site
- has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
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 |
|---|---|---|
| Loxoprofen Pain PatchOne Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days | Drug | Loxoprofen Pain Patch |
| Placebo PatchOne Placebo Patch applied daily for 3 days | Drug | Placebo Patch |
| No TreatmentNo Treatment for 3 days | Drug | No Treatment |
Primary outcome
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
Time frame: 0-24 hours
6 secondary outcomes
Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest
Time frame: 0-24 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement
Time frame: 0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest
Time frame: 0-48 hours
Time to onset of first perceptible pain relief
Time frame: First 4 hours after Dose 1
Time to onset of meaningful pain relief
Time frame: First 4 hours after Dose 1
Subjects global impression of medication
Time frame: Day 10
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 28 Oct 2016.
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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.
Derek Muse, MD principal investigator
Jean Brown Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loxoprofen Pain Patch and No Treatment in people with Delayed Onset Muscle Soreness, run by Lead Chemical Co., Ltd. at 1 site in United States.
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 3 inclusion and 6 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2016.