PainPhase 2NCT02324985
Phase II Study of AP0302 5% Versus a Vehicle Comparator
A Phase 2 study testing S-Ibuprofen Topical Gel 5% in people with Pain and Delayed Onset Muscle Soreness, run by Aponia Laboratories, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Delayed Onset Muscle Soreness
- What is being tested?
- S-Ibuprofen Topical Gel 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no clinically significant medical conditions
- BMI between 18-30
- negative drug, alcohol, pregnancy screens
- other protocol-defined inclusion criteria may apply
Who cannot join
- no upper extremity workout in last 6 months
- no job requiring heavy lifting
- history of muscle disorders
- allergy or intolerance to study drug
- history of recent pain medication use
- other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors
This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).
- Conditions
- Pain, Delayed Onset Muscle Soreness
- Being tested
- S-Ibuprofen Topical Gel 5%, Vehicle Topical Gel
- Keywords
- muscle soreness
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Ibuprofen Topical Gel 5%Drug
Also called Active Gel
S-Ibuprofen Topical Gel 5% applied every 6 hours
Vehicle Topical GelDrug
Also called Vehicle Gel
Vehicle Topical Gel applied every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Active comparator | S-Ibuprofen Topical Gel 5% Receives: Drug: S-Ibuprofen Topical Gel 5% |
| Placebo Arm | Placebo comparator | Vehicle Topical Gel Receives: Drug: Vehicle Topical Gel |
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 (SPID24) with movement
SPID 24
Measured: 0-24 hours
Secondary outcomes (2)
Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement
SPID 48movement
Measured: 0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest
SPID 48rest
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aponia Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Singla, DO, Principal investigator, Lotus Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324985
- Sponsor's protocol ID
- AP-005
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2014
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors
- ClinicalTrials.gov ID
- NCT02324985
- Acronym / sponsor ID
- AP-005
- Conditions
- Pain, Delayed Onset Muscle Soreness
- Keywords
- muscle soreness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Aponia Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Dec 2014 (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 is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).
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 |
|---|---|---|
| Active Arm | Active comparator | Drug: S-Ibuprofen Topical Gel 5%S-Ibuprofen Topical Gel 5% |
| Placebo Arm | Placebo comparator | Drug: Vehicle Topical GelVehicle Topical Gel |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- no clinically significant medical conditions
- BMI between 18-30
- negative drug, alcohol, pregnancy screens
- other protocol-defined inclusion criteria may apply
Key exclusion criteria (6 listed)
- no upper extremity workout in last 6 months
- no job requiring heavy lifting
- history of muscle disorders
- allergy or intolerance to study drug
- history of recent pain medication use
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 |
|---|---|---|
| S-Ibuprofen Topical Gel 5%Also: Active GelS-Ibuprofen Topical Gel 5% applied every 6 hours | Drug | Active Arm |
| Vehicle Topical GelAlso: Vehicle GelVehicle Topical Gel applied every 6 hours | Drug | Placebo Arm |
Primary outcome
Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement
Time frame: 0-24 hours
SPID 24
2 secondary outcomes
Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement
Time frame: 0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest
Time frame: 0-48 hours
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 25 Feb 2019.
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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.
Sonia Singla, DO principal investigator
Lotus Clinical 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 S-Ibuprofen Topical Gel 5% in people with Pain and Delayed Onset Muscle Soreness, run by Aponia Laboratories, Inc. 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 4 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 25 Feb 2019. 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 (SPID24) 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 25 Feb 2019.