COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)

NCT03223519 | Completed Phase 2

• 2 other identifiers: JAN12006-092016-003139-39
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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 (DOMS).

Conditions

Delayed Onset Muscle Soreness, DOMS

Keywords

DOMS; Exercise; Ibuprofen; Magnesium; Vitamin C; Muscle pain

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference (SPID) while standing up and sitting down.

  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.

  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.

  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.

  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.

  Over the first 72 hours after start of treatment.

• Pain intensity difference (PID) while standing up and sitting down and while walking from baseline.

  At 24 hours, 48 hours, 72 hours and 6-7 days after start of treatment.

Study Arms (5)

Comboprofen

EXPERIMENTAL

Triple combination of Ibuprofen, Magnesium and Vitamin C.

Drug: Comboprofen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Ibuprofen

ACTIVE COMPARATOR

Drug: Ibuprofen

Magnesium

ACTIVE COMPARATOR

Drug: Magnesium

Vitamin C

ACTIVE COMPARATOR

Drug: Vitamin C

Interventions

Comboprofen DRUG

Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days

Comboprofen

Placebo DRUG

Powder for oral solution administered TID for 3 days

Placebo

Ibuprofen DRUG

Powder for oral solution administered TID for 3 days

Ibuprofen

Magnesium DRUG

Powder for oral solution administered TID for 3 days

Magnesium

Vitamin C DRUG

Powder for oral solution administered TID for 3 days

Vitamin C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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
• Subjects who have been engaged in regular lower extremity fitness activities within 4 days prior to visit 2 (induction of DOMS).

Sponsors & Collaborators

• Spherium Biomed: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator

Study Sites (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Motor Activity; Myalgia

Interventions

Ibuprofen; Magnesium; Ascorbic Acid

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Sugar Acids; Acids, Acyclic; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 12, 2017
• Primary Completion: November 24, 2017
• Study Completion: November 28, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

ES (1)