Delayed Onset Muscle SorenessPhase 4DOMSNCT02113566
A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
A Phase 4 study testing Acetaminophen 1000mg in people with Delayed Onset Muscle Soreness, run by Jean Brown Research at 1 site in United States.
Trial summary
The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Acetaminophen 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2013
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- are male or female, 18-55 years of age
- are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
- have a history of experiencing muscle soreness after moderately strenuous exercise
- are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
- are able to read, comprehend, and sign the informed consent form
- develop 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 NRS (numerical rating scale) and at least "moderate" on the categorical scale
Who cannot join
- regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
- works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
- allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
- the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
- any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
- current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
Show all 15Show fewer
- currently on chronic NSAID therapy for any reason
- current or recent history of drug or alcohol abuse
- has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
- has donated blood within the past 30 days
- is unable to swallow whole or large tablets or capsules
- is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
- participation in an investigational study within the past 30 days of screening
- prior participation in this trial
- site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.
The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Acetaminophen 1000mg
- Keywords
- Delayed onset muscle soreness, DOMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 1000mgDrug
Also called Tylenol
Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg. Receives: Drug: Acetaminophen 1000mg |
| Ibuprofen | Active comparator | 2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg. Receives: Drug: Acetaminophen 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID (Sum Pain Intensity Difference)
The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)
Measured: 0-48 hours
Secondary outcomes (3)
spontaneous muscle pain/soreness
Measured: 0-48 hours
Muscle stiffness with movement
Measured: 0-48 hours
Overall evaluation measures
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 posted14 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Brown Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Muse, Jean Brown Research
- Investigators
- Derek Muse, MD, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113566
- Sponsor's protocol ID
- JBR-001
- Acronym
- DOMS
- Status last verified
- Dec 2015
- First submitted
- 6 Apr 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.
- ClinicalTrials.gov ID
- NCT02113566
- Acronym / sponsor ID
- DOMS / JBR-001
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- Delayed onset muscle soreness, DOMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jean Brown ResearchUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Apr 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.
The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Acetaminophen 1000mg2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg. |
| Ibuprofen | Active comparator | Drug: Acetaminophen 1000mg2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- are male or female, 18-55 years of age
- are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
- have a history of experiencing muscle soreness after moderately strenuous exercise
- are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
- are able to read, comprehend, and sign the informed consent form
Key exclusion criteria (15 listed)
- regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
- works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
- allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
- the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
- any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
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 |
|---|---|---|
| Acetaminophen 1000mgAlso: TylenolSubjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm. | Drug | Ibuprofen, Placebo |
Primary outcome
SPID (Sum Pain Intensity Difference)
Time frame: 0-48 hours
The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)
3 secondary outcomes
spontaneous muscle pain/soreness
Time frame: 0-48 hours
Muscle stiffness with movement
Time frame: 0-48 hours
Overall evaluation measures
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 2 Dec 2015.
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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 4 study testing Acetaminophen 1000mg in people with Delayed Onset Muscle Soreness, run by Jean Brown Research 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 6 inclusion and 15 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 2 Dec 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
SPID (Sum Pain Intensity Difference) (time frame: 0-48 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 2 Dec 2015.