ID

34661

Description

A Clinical Evaluation Of The Safety Of Baclofen Er Capsules (Grs) When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (Ms): An Open Label, Long Term, Safety Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01797185

Link

https://clinicaltrials.gov/show/NCT01797185

Keywords

Versions (1)
  1. 1/22/19 1/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Spasticity NCT01797185

English

Eligibility Spasticity NCT01797185

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT01797185
Criteria
Description

Criteria

men and women ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. the practice of contraception must have started at least 3 months prior to trial entry.
Description

Childbearing Potential Sexually active Contraceptive methods | Female Condoms | Vaginal Foam Contraception | Vaginal Gel Contraception | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Partner had vasectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0221829
UMLS CUI [3,1]
C0042254
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0042257
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C1262153
UMLS CUI [9]
C0589114
UMLS CUI [10]
C0278321
UMLS CUI [11]
C0020699
UMLS CUI [12]
C0420842
if female, negative pregnancy test result at screening
Description

Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
diagnosed with ms and a known history of spasticity
Description

Multiple Sclerosis | Spasticity

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0026838
meet one of the following criteria
Description

Criteria Fulfill Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1265611
subjects who completed the double-blind randomized withdrawal phase (part 3) of trial clr_09_21 with no major protocol violation
Description

Completion of clinical trial Phase Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C1710475
UMLS CUI [1,3]
C0205369
subjects who are newly diagnosed with spasticity due to ms with no history of treatment using any anti-spasticity medications, or, with a history of spasticity due to ms but with no previous exposure to baclofen treatment
Description

Spasticity Due to Multiple Sclerosis | Antispasticity Agents Absent | Baclofen Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0026838
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0026769
UMLS CUI [2,1]
C4020576
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0004609
UMLS CUI [3,2]
C0332197
subjects who are receiving a stable baclofen ir dose (ie, a dose of 10 mg to 80 mg daily, having started at least 30 days prior to enrollment)
Description

Baclofen Dose Stable U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0004609
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
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Similar models

Eligibility Spasticity NCT01797185

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT01797185
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Sexually active Contraceptive methods | Female Condoms | Vaginal Foam Contraception | Vaginal Gel Contraception | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Partner had vasectomy
Item
sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. the practice of contraception must have started at least 3 months prior to trial entry.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0221829 (UMLS CUI [2])
C0042254 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0042257 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0042241 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0589114 (UMLS CUI [9])
C0278321 (UMLS CUI [10])
C0020699 (UMLS CUI [11])
C0420842 (UMLS CUI [12])
Gender Pregnancy test negative
Item
if female, negative pregnancy test result at screening
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Multiple Sclerosis | Spasticity
Item
diagnosed with ms and a known history of spasticity
boolean
C0026769 (UMLS CUI [1])
C0026838 (UMLS CUI [2])
Criteria Fulfill Quantity
Item
meet one of the following criteria
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Completion of clinical trial Phase Specified
Item
subjects who completed the double-blind randomized withdrawal phase (part 3) of trial clr_09_21 with no major protocol violation
boolean
C2732579 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Spasticity Due to Multiple Sclerosis | Antispasticity Agents Absent | Baclofen Absent
Item
subjects who are newly diagnosed with spasticity due to ms with no history of treatment using any anti-spasticity medications, or, with a history of spasticity due to ms but with no previous exposure to baclofen treatment
boolean
C0026838 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C4020576 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004609 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Baclofen Dose Stable U/day
Item
subjects who are receiving a stable baclofen ir dose (ie, a dose of 10 mg to 80 mg daily, having started at least 30 days prior to enrollment)
boolean
C0004609 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
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