Delayed Onset Muscle SorenessPhase 2DIS DOMSNCT02339129
Dosing Interval Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness
A Phase 2 study testing SST-0225 in people with Delayed Onset Muscle Soreness, run by Strategic Science & Technologies, LLC at 2 sites in United States.
Trial summary
This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- SST-0225
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Mar 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Healthy male and female subjects between 16 and 65 years of age.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site #201
South Miami, Florida, 33143
Site #202
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Dosing Interval, Efficacy, and Safety of SST-0225, a Topical Ibuprofen Cream, in the Treatment of Delayed Onset Muscle Soreness (DOMS)
This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.
Read the detailed description
This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.
As part of the screening process, in the evening of Day -2, eligible subjects will undergo an exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm (see Section 11). 36 (±2) hours following the exercise regimen, subjects will return to the clinic and be evaluated for eligibility into the active treatment phase of the study. Eligible subjects who experience a sufficient level of pain 36 (± 2) hours after exercise will be randomized to receive either SST-0225 or placebo.
For the first 24 hour dosing period, the subject will remain in the clinic (on-site). Subjects will apply the first dose of Investigational Product (IP) at randomization (0 hours) and a second dose upon request (PRN or as needed). All subsequent doses will be applied every 5 (±1) hours. The total number of doses shall not exceed 6 in this first 24 hour period. Subjects will also not be allowed to take any rescue medication during the first 24 hour dosing period.
Subjects will complete the Visual Analog Scale (VAS) pain/soreness on movement assessments at the following time points while on-site the first 24 hours: 0 (prior to first dose of IP), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, and 24 hours post first dose of IP and immediately prior to the second dose of IP. All assessments must be completed unless the subject is asleep. Subjects will be restricted to a maximum of 8 hours of sleep in order to limit the number of missing VAS pain/soreness on movement assessments due to sleep. Immediately upon wakening on Day 2, subjects will be instructed to apply a dose of IP unless it has been less than 5 (±1) hours since their last dose of IP.
After subjects complete their 24 hour VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the second 24 hour dosing period.
During the second 24 hour dosing period (24-48 hours post first dose of IP), the subject will be away from the clinic (off-site) and will apply the IP every 5 (±1) hours. The total number of doses shall not exceed 6 doses in this second 24 hour period. Rescue medication will be made available to subjects during this second 24 hour period. During this second 24 hour period, subjects will complete the VAS pain/soreness on movement assessment prior to each IP dose and at 1 hour post each dose of IP.
Refer to the Schedule of Evaluations in Appendix A (on-site evaluations) and Appendix B (off-site evaluations) for details regarding the timing of study procedures.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- SST-0225, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SST-0225Drug
Also called Topical Ibuprofen Cream
SST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts.
PlaceboDrug
Placebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream.
| Study group | Role | What they receive |
|---|---|---|
| SST-0225 | Experimental | Subjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose upon request (PRN), and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours. Receives: Drug: SST-0225 |
| Placebo | Placebo comparator | Subjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose upon request (PRN), and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID24 (calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline)
The primary efficacy endpoint will be the time weighted summed pain/soreness intensity difference from baseline VAS pain/soreness on movement assessments over the first 24 hours (SPID24) following the first application of IP on Day 1. SPID24 will be calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline (pre-dose on Day 1) to 24 hours (using actual reported VAS assessment times) post first dose of IP on Day 1.
Measured: First 24 hours after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionMar 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, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strategic Science & Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard I Schwartz, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339129
- Sponsor's protocol ID
- SST0225-US-111-001A
- Acronym
- DIS DOMS
- Status last verified
- Sep 2016
- First submitted
- 12 Jan 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Dosing Interval, Efficacy, and Safety of SST-0225, a Topical Ibuprofen Cream, in the Treatment of Delayed Onset Muscle Soreness (DOMS)
- ClinicalTrials.gov ID
- NCT02339129
- Acronym / sponsor ID
- DIS DOMS / SST0225-US-111-001A
- Conditions
- Delayed Onset Muscle Soreness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Strategic Science & Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jan 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 is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.
Detailed description
This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.
As part of the screening process, in the evening of Day -2, eligible subjects will undergo an exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm (see Section 11). 36 (±2) hours following the exercise regimen, subjects will return to the clinic and be evaluated for eligibility into the active treatment phase of the study. Eligible subjects who experience a sufficient level of pain 36 (± 2) hours after exercise will be randomized to receive either SST-0225 or placebo.
For the first 24 hour dosing period, the subject will remain in the clinic (on-site). Subjects will apply the first dose of Investigational Product (IP) at randomization (0 hours) and a second dose upon request (PRN or as needed). All subsequent doses will be applied every 5 (±1) hours. The total number of doses shall not exceed 6 in this first 24 hour period. Subjects will also not be allowed to take any rescue medication during the first 24 hour dosing period.
Subjects will complete the Visual Analog Scale (VAS) pain/soreness on movement assessments at the following time points while on-site the first 24 hours: 0 (prior to first dose of IP), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, and 24 hours post first dose of IP and immediately prior to the second dose of IP. All assessments must be completed unless the subject is asleep. Subjects will be restricted to a maximum of 8 hours of sleep in order to limit the number of missing VAS pain/soreness on movement assessments due to sleep. Immediately upon wakening on Day 2, subjects will be instructed to apply a dose of IP unless it has been less than 5 (±1) hours since their last dose of IP.
After subjects complete their 24 hour VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the second 24 hour dosing period.
During the second 24 hour dosing period (24-48 hours post first dose of IP), the subject will be away from the clinic (off-site) and will apply the IP every 5 (±1) hours. The total number of doses shall not exceed 6 doses in this second 24 hour period. Rescue medication will be made available to subjects during this second 24 hour period. During this second 24 hour period, subjects will complete the VAS pain/soreness on movement assessment prior to each IP dose and at 1 hour post each dose of IP.
Refer to the Schedule of Evaluations in Appendix A (on-site evaluations) and Appendix B (off-site evaluations) for details regarding the timing of study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SST-0225 | Experimental | Drug: SST-0225Subjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose upon request (PRN), and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose upon request (PRN), and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose VAS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| SST-0225Also: Topical Ibuprofen CreamSST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts. | Drug | SST-0225 |
| PlaceboPlacebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream. | Drug | Placebo |
Primary outcome
SPID24 (calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline)
Time frame: First 24 hours after first dose
The primary efficacy endpoint will be the time weighted summed pain/soreness intensity difference from baseline VAS pain/soreness on movement assessments over the first 24 hours (SPID24) following the first application of IP on Day 1. SPID24 will be calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline (pre-dose on Day 1) to 24 hours (using actual reported VAS assessment times) post first dose of IP on Day 1.
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 9 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Howard I Schwartz, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SST-0225 in people with Delayed Onset Muscle Soreness, run by Strategic Science & Technologies, LLC at 2 sites 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?
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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
SPID24 (calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline) (time frame: First 24 hours after first dose). 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 9 Sep 2016.