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Trial record 32 of 22179 for:    Placebo AND subjects

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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ClinicalTrials.gov Identifier: NCT03807219
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Naveh Pharma LTD

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

Condition or disease Intervention/treatment Phase
Nocturnal Leg Cramps Dietary Supplement: Magnox Comfort Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2018
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arm Intervention/treatment
Active Comparator: Magnox Comfort
80 subjects will be on the Magnox Comfort arm.
Dietary Supplement: Magnox Comfort
Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).

Placebo Comparator: Placebo
80 subjects will be on the Placebo arm.
Other: Placebo
placebo




Primary Outcome Measures :
  1. The number of episodes of NLC [ 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. ]
    The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary


Secondary Outcome Measures :
  1. Duration of NLC [ 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. ]
    The study subject will record the length of cramps in the diary

  2. Severity of pain associated with NLC [ 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. ]
    The study subject will record the severity of cramps in the diary using the visual analog scale from 0 to 10

  3. Change in quality of life (SF-36) [ 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. ]
    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.

  4. Changing in the sleep quality [ 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. ]
    The evaluation will be conducted using VAS (visual analog scale) from 0 to 5

  5. Drop-out rate [ 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. ]
    Counts of drop-out subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. A study subject is a man or a woman over the age of 45 years;
  3. The study subject has an established diagnosis of the nocturnal legs cramps;
  4. The study subject understands the Ukrainian language;
  5. The study subject has satisfactory results of the neurological examination of both lower extremities;
  6. The study subject has a telephone and can use it permanently;

Exclusion Criteria:

  1. The onset of one of the non-inclusion criteria;
  2. The study subject has less than 4 episodes of NLC during the 14-day screening period;
  3. There is necessity for significant change in the treatment tactics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807219


Locations
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Ukraine
Kharkiv City Clinic №9
Kharkiv, Kharkiv Region, Ukraine
Kyiv city clinic №9
Kyiv, Kyiv Region, Ukraine
Medical Center "Artem"
Kyiv, Kyiv Region, Ukraine
Medical Center "Preventclinic" LLC
Kyiv, Kyiv Region, Ukraine
City clinic №5
Lviv, Lviv Region, Ukraine
Odesa Railway City Clinic
Odesa, Odesa Region, Ukraine
Medical center "Desna" LLC
Ternopil', Ternopil` Region, Ukraine
Sponsors and Collaborators
Naveh Pharma LTD
Investigators
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Study Director: Nitsan Primor Naveh Pharma LTD

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Responsible Party: Naveh Pharma LTD
ClinicalTrials.gov Identifier: NCT03807219     History of Changes
Other Study ID Numbers: FS-MAG-1907
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naveh Pharma LTD:
nocturnal legs cramps
legs cramps
NLC

Additional relevant MeSH terms:
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Sleep-Wake Transition Disorders
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders