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

Primary Purpose

Delayed Onset Muscle Soreness, DOMS

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Comboprofen
Placebo
Ibuprofen
Magnesium
Vitamin C
Sponsored by
Spherium Biomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Onset Muscle Soreness, DOMS focused on measuring DOMS, Exercise, Ibuprofen, Magnesium, Vitamin C, Muscle pain

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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 (Centre d'Investigació de Medicaments)-Sant Pau.
  6. 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.
  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 (Clinical Research Ethic Committee).
  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.

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Comboprofen

Placebo

Ibuprofen

Magnesium

Vitamin C

Arm Description

Triple combination of Ibuprofen, Magnesium and Vitamin C.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Summed Pain Intensity Difference (SPID) while standing up and sitting down and while walking.
Percentage of subjects achieving at least 50% or 70% reduction in pain intensity vs baseline while standing up and sitting down and while walking.
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 to reduction of at least 50% or 70% pain intensity vs baseline while standing up and sitting down and while walking.
Pain intensity difference (PID) while standing up and sitting down and while walking from baseline.
Pain intensity difference (PID) while ascending and descending 9-step flight of stairs from baseline.
Change in pain intensity while descending 9-step flight of stairs from baseline.
Percentage of subjects achieving at least 80% or 100% recovery of baseline maximal isometric force.
Change in perception of loss of strength induced by Comboprofen from baseline.

Full Information

First Posted
July 17, 2017
Last Updated
January 22, 2018
Sponsor
Spherium Biomed
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT03223519
Brief Title
COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
November 24, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spherium Biomed
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Onset Muscle Soreness, DOMS
Keywords
DOMS, Exercise, Ibuprofen, Magnesium, Vitamin C, Muscle pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comboprofen
Arm Type
Experimental
Arm Description
Triple combination of Ibuprofen, Magnesium and Vitamin C.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Title
Magnesium
Arm Type
Active Comparator
Arm Title
Vitamin C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Comboprofen
Intervention Description
Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Powder for oral solution administered TID for 3 days
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Powder for oral solution administered TID for 3 days
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
Powder for oral solution administered TID for 3 days
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
Powder for oral solution administered TID for 3 days
Primary Outcome Measure Information:
Title
Summed Pain Intensity Difference (SPID) while standing up and sitting down.
Time Frame
Over the first 72 hours after start of treatment.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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).
Facility Information:
Facility Name
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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