Delayed onset muscular soreness
Conditions
Interventions
Product Name: ibuprofen
Product Code: JAN12006-F03
Pharmaceutical Form: Granules for oral solution in sachet
INN or Proposed INN: IBUPROFEN
Other descriptive name: IBUPROFEN (LYSINE)
Concentration uni
Sponsors
Spherium Biomed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment. 2. Body weight within normal range (Quetelet’s index between 19 and 30) expressed as weight (kg) / height (m2). 3. Normal clinical records and physical examination. 4. No known musculoskeletal pathology. 5. 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-Sant Pau. 6. Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting. 7. To be able to understand the nature of the study and comply with all their requirements. 8. Free acceptance to participate in the study by obtaining signed informed consent form approved by the CREC. 9. 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. 10. Report 24 or 48 hours post exercise, a pain intensity score = 4 in a 11 point-NRS scale while walking. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice. 3. Background of allergy, idiosyncrasy or hypersensitivity to drugs. 4. 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. 5. Positive serology for hepatitis B, C or HIV. 6. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases. 7. 12 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. 8. Having undergone major surgery during the previous 6 months. 9. Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration. 10. Participation in another clinical trial during the 3 months preceding the drug administration. 11. Donation of blood during the 4 weeks preceding the drug administration. 12. Acute illness four weeks before drug administration. 13. Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation. 14. 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 15. Positive results of the drugs at screening period, the day before starting induction of DOMS or 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). 16. Subjects who have been engaged in regular lower extremity fitness activities within 4 days prior to visit 2 (induction of DOMS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Safety and Efficacy of Comboprofen versus: - Ibuprofen monotherapy (200 mg) - Placebo - Magnesium monotherapy (40 mg) - Vitamin C monotherapy (166.5 mg);Secondary Objective: "Not applicable";Primary end point(s): SPID while walking over the first 72 hours after start of treatment with Comboprofen compared to Ibuprofen, to placebo, to magnesium and to vitamin C.;Timepoint(s) of evaluation of this end point: over the first 72 hours after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain assessment Pain intensity will be measured using the 11-point NRS scale (while walking and while standing up) and the summed difference in pain intensity across the study will be compared between treatments. Pain intensity using the 11-point NRS scale will be also measured while climbing and while descending 9-step flight of stairs. Pain intensity while descending a 9-step flight of stairs measured using a 6-point DOMS likert scale will be compared between treatments. The percentage of subject’s achieving at least 50%/70% reduction in pain intensity (while walking, while standing up, while climbing and while descending 9-step flight of stairs) will be also compared between treatments. Muscle function assessment Muscle function will be measured using the Maximal Isometric Force Test and the Functional Stair Test; the percentage of subject’s achieving a specific percentage of recovery (80%/100%) across the study will be compared between treatments; also the 11-point NRS scale will be used to assess the change in perception of loss of strength Muscle damage and inflammatory assessment This endpoint will be assessed using the inflammatory and muscle injury markers specified in the protocol. The changes from baseline will be compared between treatments across the whole study period. Global assessment A 5-point categorical scale will be used, and the subjects will be asked to rate the study drug efficacy as poor, fair, good, very good or excellent. Comparisons between treatments will be made.;Timepoint(s) of evaluation of this end point: 0-120h | — |
Countries
Spain
Contacts
Public ContactSponsor representative
Spherium Biomed
Outcome results
None listed