Delayed Onset Muscle Soreness, DOMSPhase 2NCT03223519
COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)
A Phase 2 study testing Comboprofen, Ibuprofen and Magnesium in people with Delayed Onset Muscle Soreness, DOMS, run by Spherium Biomed at 1 site in Spain.
Trial summary
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness, DOMS
- What is being tested?
- Comboprofen, Ibuprofen and Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2017to 28 Nov 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
- Body weight within normal range (Quetelet's index between 19 and 30) expressed as weight (kg) / height (m2).
- Normal clinical records and physical examination.
- No known musculoskeletal pathology.
- Laboratory tests (hematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM (Centre d'Investigació de Medicaments)-Sant Pau.
- Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP (Systolic blood pressure) between 100-140 mm Hg/ DBP (Diastolic blood pressure) between 50-90 mm Hg / Heart rate between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
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- To be able to understand the nature of the study and comply with all their requirements.
- Free acceptance to participate in the study by obtaining signed informed consent form approved by the CREC (Clinical Research Ethic Committee).
- Not engaged in regular lower extremity fitness activities for more than 2 times per week for ≥ 2 consecutive weeks in the past 6 months before screening.
Who cannot join
- History of alcohol dependence or drug abuse in the last 1 year or daily consumption of alcohol > 40 g/day for men or 24 g/day for women.
- Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
- Background of allergy, idiosyncrasy or hypersensitivity to drugs.
- Intake of any medication within 4 days prior to induction of DOMS that could interfere with pain or muscle function, including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), any source of Magnesium and Vitamin C and ionic and protein supplements.
- Positive serology for hepatitis B, C or HIV.
- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
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- Twelve lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
- Having undergone major surgery during the previous 6 months.
- Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
- Participation in another clinical trial during the 3 months preceding the drug administration.
- Donation of blood during the 4 weeks preceding the drug administration.
- Acute illness four weeks before drug administration.
- Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation.
- Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract
- Positive results of the drugs at screening period, at visit 2 before starting induction of DOMS or at visit 3 before starting treatment. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the PI).
- Subjects who have been engaged in regular lower extremity fitness activities within 4 days prior to visit 2 (induction of DOMS).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Single-center, Exploratory Clinical Trial to Investigate Safety and Efficacy of COMBOPROFEN for Treatment of Muscular Pain Associated With DOMS.
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).
Read the detailed description
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).
Healthy volunteers will be recruited to undergo a controlled exercise test designed to induce DOMS in lower limbs. Subjets reporting sufficient pain intensity while walking in an 11-point Numerical Rating Scale (NRS) 24h or 48 h after exercise will be randomized to receive treatment with Comboprofen, placebo, ibuprofen, magnesium or vitamin c three times a day (TID) for 3 days.
Once a subject is randomized the duration of participation will be 7 days. Subjects will be housed in the clinic for the first 24 hours of dosing. Pain intensity while standing up and sitting down and while walking will be assessed throughout the study using an 11-point (0-10) Numeric Rating Scale (NRS). Maximal isometric force, muscle damage and inflammatory markers will be also assessed throughout the study.
- Conditions
- Delayed Onset Muscle Soreness, DOMS
- Keywords
- DOMS, Exercise, Ibuprofen, Magnesium, Vitamin C, Muscle pain
- Medical subject headings
- Motor Activity, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComboprofenDrug
Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days
PlaceboDrug
Powder for oral solution administered TID for 3 days
IbuprofenDrug
Powder for oral solution administered TID for 3 days
MagnesiumDrug
Powder for oral solution administered TID for 3 days
Vitamin CDrug
Powder for oral solution administered TID for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Comboprofen | Experimental | Triple combination of Ibuprofen, Magnesium and Vitamin C. Receives: Drug: Comboprofen |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
| Magnesium | Active comparator | Not described Receives: Drug: Magnesium |
| Vitamin C | Active comparator | Not described Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference (SPID) while standing up and sitting down.
Measured: Over the first 72 hours after start of treatment.
Secondary outcomes (9)
Summed Pain Intensity Difference (SPID) while standing up and sitting down and while walking.
Measured: Over the first 24, 48 and 72 hours after start of treatment.
Percentage of subjects achieving at least 50% or 70% reduction in pain intensity vs baseline while standing up and sitting down and while walking.
Measured: Over the first 24, 48 and 72 hours after start of treatment.
Percentage os subjects achieving at least 50% or 70% reduction in pain intensity vs baseline while climbing 9-step flight of stairs and while descending 9-step flight of stairs.
Measured: Over the first 24 and 72 hours after start of treatment.
Time to reduction of at least 50% or 70% pain intensity vs baseline while standing up and sitting down and while walking.
Measured: Over the first 72 hours after start of treatment.
Pain intensity difference (PID) while standing up and sitting down and while walking from baseline.
Measured: At 24 hours, 48 hours, 72 hours and 6-7 days after start of treatment.
Pain intensity difference (PID) while ascending and descending 9-step flight of stairs from baseline.
Measured: At 24 hours, 72 hours and 6-7 days after start of treatment.
Change in pain intensity while descending 9-step flight of stairs from baseline.
Measured: At 24 hours, 72 hours and 6-7 days after start of treatment.
Percentage of subjects achieving at least 80% or 100% recovery of baseline maximal isometric force.
Measured: At 24 hours, 72 hours and 6-7 days after start of treatment.
Change in perception of loss of strength induced by Comboprofen from baseline.
Measured: At 24 hours, 72 hours and 6-7 days after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start12 Jul 2017
- Primary completion24 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle Soreness, DOMSStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spherium Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223519
- Sponsor's protocol ID
- JAN12006-09
- Other IDs
- 2016-003139-39, 2016
- Status last verified
- Jan 2018
- First submitted
- 17 Jul 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Single-center, Exploratory Clinical Trial to Investigate Safety and Efficacy of COMBOPROFEN for Treatment of Muscular Pain Associated With DOMS.
- ClinicalTrials.gov ID
- NCT03223519
- Acronym / sponsor ID
- JAN12006-09
- Conditions
- Delayed Onset Muscle Soreness, DOMS
- Keywords
- DOMS, Exercise, Ibuprofen, Magnesium, Vitamin C, Muscle pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Spherium BiomedIndustry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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 study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).
Detailed description
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).
Healthy volunteers will be recruited to undergo a controlled exercise test designed to induce DOMS in lower limbs. Subjets reporting sufficient pain intensity while walking in an 11-point Numerical Rating Scale (NRS) 24h or 48 h after exercise will be randomized to receive treatment with Comboprofen, placebo, ibuprofen, magnesium or vitamin c three times a day (TID) for 3 days.
Once a subject is randomized the duration of participation will be 7 days. Subjects will be housed in the clinic for the first 24 hours of dosing. Pain intensity while standing up and sitting down and while walking will be assessed throughout the study using an 11-point (0-10) Numeric Rating Scale (NRS). Maximal isometric force, muscle damage and inflammatory markers will be also assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Comboprofen | Experimental | Drug: ComboprofenTriple combination of Ibuprofen, Magnesium and Vitamin C. |
| Placebo | Placebo comparator | Drug: Placebo |
| Ibuprofen | Active comparator | Drug: Ibuprofen |
| Magnesium | Active comparator | Drug: Magnesium |
| Vitamin C | Active comparator | Drug: Vitamin C |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
- Body weight within normal range (Quetelet's index between 19 and 30) expressed as weight (kg) / height (m2).
- Normal clinical records and physical examination.
- No known musculoskeletal pathology.
- Laboratory tests (hematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM (Centre d'Investigació de Medicaments)-Sant Pau.
Key exclusion criteria (16 listed)
- History of alcohol dependence or drug abuse in the last 1 year or daily consumption of alcohol > 40 g/day for men or 24 g/day for women.
- Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
- Background of allergy, idiosyncrasy or hypersensitivity to drugs.
- Intake of any medication within 4 days prior to induction of DOMS that could interfere with pain or muscle function, including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), any source of Magnesium and Vitamin C and ionic and protein supplements.
- Positive serology for hepatitis B, C or HIV.
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 |
|---|---|---|
| ComboprofenTriple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days | Drug | Comboprofen |
| PlaceboPowder for oral solution administered TID for 3 days | Drug | Placebo |
| IbuprofenPowder for oral solution administered TID for 3 days | Drug | Ibuprofen |
| MagnesiumPowder for oral solution administered TID for 3 days | Drug | Magnesium |
| Vitamin CPowder for oral solution administered TID for 3 days | Drug | Vitamin C |
Primary outcome
Summed Pain Intensity Difference (SPID) while standing up and sitting down.
Time frame: Over the first 72 hours after start of treatment.
9 secondary outcomes
Summed Pain Intensity Difference (SPID) while standing up and sitting down and while walking.
Time frame: Over the first 24, 48 and 72 hours after start of treatment.
Percentage of subjects achieving at least 50% or 70% reduction in pain intensity vs baseline while standing up and sitting down and while walking.
Time frame: Over the first 24, 48 and 72 hours after start of treatment.
Percentage os subjects achieving at least 50% or 70% reduction in pain intensity vs baseline while climbing 9-step flight of stairs and while descending 9-step flight of stairs.
Time frame: Over the first 24 and 72 hours after start of treatment.
Time to reduction of at least 50% or 70% pain intensity vs baseline while standing up and sitting down and while walking.
Time frame: Over the first 72 hours after start of treatment.
Pain intensity difference (PID) while standing up and sitting down and while walking from baseline.
Time frame: At 24 hours, 48 hours, 72 hours and 6-7 days after start of treatment.
Pain intensity difference (PID) while ascending and descending 9-step flight of stairs from baseline.
Time frame: At 24 hours, 72 hours and 6-7 days after start of treatment.
Change in pain intensity while descending 9-step flight of stairs from baseline.
Time frame: At 24 hours, 72 hours and 6-7 days after start of treatment.
Percentage of subjects achieving at least 80% or 100% recovery of baseline maximal isometric force.
Time frame: At 24 hours, 72 hours and 6-7 days after start of treatment.
Change in perception of loss of strength induced by Comboprofen from baseline.
Time frame: At 24 hours, 72 hours and 6-7 days after start of treatment.
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 23 Jan 2018.
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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.
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 Comboprofen, Ibuprofen and Magnesium in people with Delayed Onset Muscle Soreness, DOMS, run by Spherium Biomed at 1 site in Spain.
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 9 inclusion and 16 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 23 Jan 2018. 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 Spain. 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?
Summed Pain Intensity Difference (SPID) while standing up and sitting down. (time frame: Over the first 72 hours after start of treatment.). 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 23 Jan 2018.