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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days
Powder for oral solution administered TID for 3 days
Powder for oral solution administered TID for 3 days
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Summed Pain Intensity Difference (SPID) while standing up and sitting down.
Time frame: Over the first 72 hours after start of treatment.
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.
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Powder for oral solution administered TID for 3 days
Powder for oral solution administered TID for 3 days
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.