None listed
Conditions
Interventions
Trade Name: Magné B6 48 mg/5 mg coated tablets
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Magnesium Lactate Dihydrate
Other descriptive name: MAGNESIUM LACTATE DIHYDRATE
Concentration un
Sponsors
Sanofi-Aventis Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female subjects aged between 18 and 50 years, chronically stressed (screening DASS-42 scale for chronic stress >18). -Signed written informed consent. -Moderate hypomagnesemic and low serum magnesium level subjects (0.5mmol/L 18.5 and =29.9 kg/m^2. -Able to understand the study, including risks and adverse events; collaborating with Investigator and proceeding according with protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 264 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Any technical/administrative reason (eg, subject homeless) that makes it impossible to randomize the patient in the study. -Subject who has previously participated in any clinical trial of Magne B6 or Magnespasmyl. -Subject who has taken other investigational drugs or prohibited therapy for this study within 3 months from screening. -Conditions/situations such as: -Subjects with conditions/concomitant diseases making them non evaluable for the primary endpoint. -Requirement for concomitant treatment that could bias primary endpoint. -Impossibility to meet specific protocol requirements (eg, for hospitalization). -Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. -Subject not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions or subjects potentially at risk of noncompliance to study procedures. -Subjects with severe hypomagnesemia (serum magnesium less than or equal to 0.45 mmol/L). -Subjects with moderate and severe kidney failure. -Subjects treated with Levodopa. -Subjects treated with quinidine. -Any known allergies to the test substances, or with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency due to sucrose content (excipient). -Any known addiction to drugs and alcohol. -Alcohol intake of at least 3 drinks/day. -Type 1 or 2 diabetes mellitus. -Active neoplasms. -Known hyperthyroidism unless treated and under control. -History of hepatic, renal, pulmonary, gastrointestinal, neurologic, hematologic, psychiatric, cardiac, or allergic disease clinically relevant. -Laboratory results out of the normal range. In this case, subject can be included if the alterations are considered by the doctor as not relevant. -The subject has an excessive tobacco consumption (smokes more than 10 cigarettes/day). -Have used regular medication for 2 weeks before the study, except contraceptive oral method for women. -Hospitalization up to 8 weeks before the study start. -Treatment within 3 months before the study starts with a drug considered toxic. -Treatment with proton-pump inhibitors (eg, omeprazole, pantoprazole, esomeprazole, lansoprazole/dexlansoprazole, rabeprazole/dexrabeprazole) -Subject which has donate or lost 450 mL or more of blood within 3 months before the study. -Maintaining therapy with any drug, except contraceptive oral pills. -All contraindications of the Magnespasmyl or waning/precaution of use as displayed in the respective National Product Labeling that was used for defining these exclusion criteria. Any update of contraindications in labeling document (Magnespasmyl) occuring during the course of the study that should be considered systematically as a new exclusion criterion. -Pregnant, lactating, or females planning pregnancy in the next year or women with noneffective contraceptive method during the study period. -Subject who has withdrawn consent before enrollment/randomization. -Despite screening of the subject, enrollment/randomization is stopped at the study level.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of Magne B6 versus Magnespasmyl (magnesium only) supplementation on stress level, evaluated by the stress subscale from the Depression Anxiety Stress Scale (DASS)-42 test, in chronically stressed subjects with suboptimal serum magnesium levels. ;Secondary Objective: -To compare the effect of Magne B6 versus Magnespasmyl supplementation on depression and anxiety subscales from the DASS-42 test. -To compare the effect of Magne B6 versus Magnespasmyl supplementation on cortisol awakening response (CAR) measured over a 2-day period. -To compare the effect of Magne B6 versus Magnespasmyl supplementation on magnesium levels in erythrocytes. -Adverse events (AEs). ;Primary end point(s): Change from baseline of DASS-42 Stress subscale ;Timepoint(s) of evaluation of this end point: Baseline, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: a) Baseline, 4 weeks b), c), d), e), f), g) : Baseline, 4 weeks and 8 weeks ;Secondary end point(s): a)Change from baseline of DASS-42 Stress subscale b)Change from baseline of DASS-42 Anxiety subscale c)Change from baseline of DASS-42 Depression subscale d)Change from baseline in cortisol awakening response (CAR) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of CAR e)Change from baseline in absolute increase of cortisol (AINC) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of AINC f)Change from baseline in increase of cortisol (MINC) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of MINC g)Change from baseline on erythrocytes magnesium level | — |
Countries
France
Contacts
Public ContactDirection des Opérations Cliniques
Sanofi-aventis France
Outcome results
None listed