ID

24659

Description

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone; ODM derived from: https://clinicaltrials.gov/show/NCT00501696

Link

https://clinicaltrials.gov/show/NCT00501696

Keywords

Versions (1)
  1. 8/12/17 8/12/17 -
Uploaded on

August 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00501696

English

Eligibility Multiple Sclerosis NCT00501696

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically definite ms by current international criteria
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
between 18 and 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willingness to not change or start disease modifying or symptomatic therapies of ms during the trial
Description

Disease Modification Therapeutic procedure Multiple Sclerosis | Therapeutic procedure Symptomatic Multiple Sclerosis | Therapeutic procedure Specified unchanged | Therapeutic procedure Specified Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0026769
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0026769
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205369
UMLS CUI [3,3]
C0442739
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205369
UMLS CUI [4,3]
C0332197
the patient should be able to understand english
Description

Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
the patients should read, understand and sign the study informed consent form prior to any participation in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients currently on a disease modifying therapy should be on this medication for at least 3 months and not anticipate changing or discontinuing this medication during the 17 week study
Description

Disease Modification Therapeutic procedure | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Discontinuation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0332197
patients not currently on a disease modifying therapy
Description

Disease Modification Therapeutic procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0332197
for women of childbearing potential, willingness to use a barrier method of contraception during the trial
Description

Childbearing Potential Barrier Contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
start of a disease modifying therapy within 3 months of entry in the trial
Description

Disease Modification Therapeutic procedure Started

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1272689
planned start of dmt during the clinical trial
Description

Disease Modification Therapeutic procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1301732
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
current chronic opioid agonists use, i.e. any narcotic medication including hydroxycode and codeine-containing preparations
Description

Opioid Agonist chronic | Narcotics | Pharmaceutical Preparations Containing Codeine

Data type

boolean

Alias
UMLS CUI [1,1]
C1883695
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0027415
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0009214
patients under 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients older than 75 years prior to the start of therapy
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who are currently on both interferon and glatiramer acetate
Description

Interferon | glatiramer acetate

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0289884
patients who are currently taking ldn
Description

Naltrexone Low dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0027360
UMLS CUI [1,2]
C0445550
patients who are currently taking immunosuppressive medications e.g. cyclophosphamide, mitoxantrone, azathioprine, methotrexate, mycophenolate mofetil, natalizumab, rituximab, alemtuzumab or other immune suppressants
Description

Immunosuppressive Agents | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | mycophenolate mofetil | natalizumab | rituximab | alemtuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0026259
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0025677
UMLS CUI [6]
C0209368
UMLS CUI [7]
C1172734
UMLS CUI [8]
C0393022
UMLS CUI [9]
C0383429
participation in other clinical treatment trials in ms
Description

Study Subject Participation Status | Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0026769
the patients who cannot comprehend msqli54 instructions and
Description

Multiple Sclerosis Quality of Life-54 Instrument Questionnaire Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3826975
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Multiple Sclerosis NCT00501696

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
clinically definite ms by current international criteria
boolean
C0026769 (UMLS CUI [1])
Age
Item
between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Disease Modification Therapeutic procedure Multiple Sclerosis | Therapeutic procedure Symptomatic Multiple Sclerosis | Therapeutic procedure Specified unchanged | Therapeutic procedure Specified Absent
Item
willingness to not change or start disease modifying or symptomatic therapies of ms during the trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0026769 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205369 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Comprehension English Language
Item
the patient should be able to understand english
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
the patients should read, understand and sign the study informed consent form prior to any participation in the study
boolean
C0021430 (UMLS CUI [1])
Disease Modification Therapeutic procedure | Pharmaceutical Preparations unchanged | Pharmaceutical Preparations Discontinuation Absent
Item
patients currently on a disease modifying therapy should be on this medication for at least 3 months and not anticipate changing or discontinuing this medication during the 17 week study
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Disease Modification Therapeutic procedure Absent
Item
patients not currently on a disease modifying therapy
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Childbearing Potential Barrier Contraception
Item
for women of childbearing potential, willingness to use a barrier method of contraception during the trial
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Modification Therapeutic procedure Started
Item
start of a disease modifying therapy within 3 months of entry in the trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1272689 (UMLS CUI [1,4])
Disease Modification Therapeutic procedure Planned
Item
planned start of dmt during the clinical trial
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Opioid Agonist chronic | Narcotics | Pharmaceutical Preparations Containing Codeine
Item
current chronic opioid agonists use, i.e. any narcotic medication including hydroxycode and codeine-containing preparations
boolean
C1883695 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0027415 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0009214 (UMLS CUI [3,3])
Age
Item
patients under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Age
Item
patients older than 75 years prior to the start of therapy
boolean
C0001779 (UMLS CUI [1])
Interferon | glatiramer acetate
Item
patients who are currently on both interferon and glatiramer acetate
boolean
C3652465 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
Naltrexone Low dose
Item
patients who are currently taking ldn
boolean
C0027360 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
Immunosuppressive Agents | Cyclophosphamide | Mitoxantrone | Azathioprine | Methotrexate | mycophenolate mofetil | natalizumab | rituximab | alemtuzumab
Item
patients who are currently taking immunosuppressive medications e.g. cyclophosphamide, mitoxantrone, azathioprine, methotrexate, mycophenolate mofetil, natalizumab, rituximab, alemtuzumab or other immune suppressants
boolean
C0021081 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0026259 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0209368 (UMLS CUI [6])
C1172734 (UMLS CUI [7])
C0393022 (UMLS CUI [8])
C0383429 (UMLS CUI [9])
Study Subject Participation Status | Multiple Sclerosis
Item
participation in other clinical treatment trials in ms
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Multiple Sclerosis Quality of Life-54 Instrument Questionnaire Comprehension Unable
Item
the patients who cannot comprehend msqli54 instructions and
boolean
C3826975 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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