The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Primary Purpose
Nocturnal Leg Cramps
Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Magnox Comfort
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring nocturnal legs cramps, legs cramps, NLC
Eligibility Criteria
Inclusion Criteria:
- The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
- A study subject is a man or a woman over the age of 45 years;
- The study subject has an established diagnosis of the nocturnal legs cramps;
- The study subject understands the Ukrainian language;
- The study subject has satisfactory results of the neurological examination of both lower extremities;
- The study subject has a telephone and can use it permanently;
Exclusion Criteria:
- The onset of one of the non-inclusion criteria;
- The study subject has less than 4 episodes of NLC during the 14-day screening period;
- There is necessity for significant change in the treatment tactics.
Sites / Locations
- Kharkiv City Clinic №9
- Kyiv city clinic №9
- Medical Center "Artem"
- Medical Center "Preventclinic" LLC
- City clinic №5
- Odesa Railway City Clinic
- Medical center "Desna" LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnox Comfort
Placebo
Arm Description
80 subjects will be on the Magnox Comfort arm.
80 subjects will be on the Placebo arm.
Outcomes
Primary Outcome Measures
The number of episodes of NLC
The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
Secondary Outcome Measures
Duration of NLC
The study subject will record the length of cramps in the diary
Severity of pain associated with NLC
The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10
Change in quality of life (SF-36)
Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation.
Changing in the sleep quality
The evaluation will be conducted using VAS (visual analog scale) from 0 to 5
Drop-out rate
Counts of drop-out subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03807219
Brief Title
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Official Title
A Randomized, Multicenter, Prospective, Double-blind, Placebo-controlled, Clinical Trial in the Parallel Groups to Determine the Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naveh Pharma LTD
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
A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps
Detailed Description
At the beginning of the study, study subjects undergo a 14-day screening period during which the number of episodes of NLC is recorded. For further participation in the study, they must have at least 4 NLC episodes. Thereafter, an examination of compliance with the study requirements is performed and study subjects are randomized to one of the two groups: for a 60-day of IP use (1 capsule of Magnox Comfort daily) or to the control group (1 capsule of placebo daily).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Leg Cramps
Keywords
nocturnal legs cramps, legs cramps, NLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnox Comfort
Arm Type
Active Comparator
Arm Description
80 subjects will be on the Magnox Comfort arm.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
80 subjects will be on the Placebo arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnox Comfort
Intervention Description
Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
The number of episodes of NLC
Description
The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary
Time Frame
The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
Secondary Outcome Measure Information:
Title
Duration of NLC
Description
The study subject will record the length of cramps in the diary
Time Frame
The difference in duration of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
Title
Severity of pain associated with NLC
Description
The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10
Time Frame
The difference in severity of pain of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
Title
Change in quality of life (SF-36)
Description
Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation.
Time Frame
The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
Title
Changing in the sleep quality
Description
The evaluation will be conducted using VAS (visual analog scale) from 0 to 5
Time Frame
The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
Title
Drop-out rate
Description
Counts of drop-out subjects
Time Frame
The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
A study subject is a man or a woman over the age of 45 years;
The study subject has an established diagnosis of the nocturnal legs cramps;
The study subject understands the Ukrainian language;
The study subject has satisfactory results of the neurological examination of both lower extremities;
The study subject has a telephone and can use it permanently;
Exclusion Criteria:
The onset of one of the non-inclusion criteria;
The study subject has less than 4 episodes of NLC during the 14-day screening period;
There is necessity for significant change in the treatment tactics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitsan Primor
Organizational Affiliation
Naveh Pharma LTD
Official's Role
Study Director
Facility Information:
Facility Name
Kharkiv City Clinic №9
City
Kharkiv
State/Province
Kharkiv Region
Country
Ukraine
Facility Name
Kyiv city clinic №9
City
Kyiv
State/Province
Kyiv Region
Country
Ukraine
Facility Name
Medical Center "Artem"
City
Kyiv
State/Province
Kyiv Region
Country
Ukraine
Facility Name
Medical Center "Preventclinic" LLC
City
Kyiv
State/Province
Kyiv Region
Country
Ukraine
Facility Name
City clinic №5
City
Lviv
State/Province
Lviv Region
Country
Ukraine
Facility Name
Odesa Railway City Clinic
City
Odesa
State/Province
Odesa Region
Country
Ukraine
Facility Name
Medical center "Desna" LLC
City
Ternopil'
State/Province
Ternopil' Region
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34719399
Citation
Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.
Results Reference
derived
Learn more about this trial
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC
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