ID

43832

Beschreibung

Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects With Spasticity Due to Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01457352

Link

https://clinicaltrials.gov/show/NCT01457352

Stichworte

Versionen (2)
  1. 13.03.16 13.03.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Spasticity NCT01457352

Englisch

Eligibility Spasticity NCT01457352

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT01457352
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women age 18 years and older
Beschreibung

gender; age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (iud), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry or postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy)
Beschreibung

Fertility Female ; Contraception status; condoms

Datentyp

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0086287
UMLS CUI [3]
C0677582
if female, negative pregnancy test
Beschreibung

negative pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
known history of spasticity due to ms prior to starting baclofen
Beschreibung

spasticity; Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026838
UMLS CUI [2]
C0026769
a stable daily dose of baclofen ir, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
Beschreibung

dosage baclofen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0004609
able and willing to comply with the protocol, including availability for a scheduled clinic visits
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
willingness and giving of written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypersensitivity to baclofen
Beschreibung

hypersensitivity baclofen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004609
in relapse or history of unstable course over the prior 30 days prior to the screening visit
Beschreibung

disease relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
concomitant neurologic conditions causing spasticity
Beschreibung

concomitant disease neurologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243087
UMLS CUI [1,2]
C0205494
has received an investigational drug or device within 30 days that would interfere with the study goals prior to the screening visit
Beschreibung

concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
unable to comply with study procedures in the opinion of the investigator
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
has had major surgery within 3 months prior to screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Spasticity NCT01457352

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT01457352
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
gender; age
Item
men and women age 18 years and older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Fertility Female ; Contraception status; condoms
Item
women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (iud), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry or postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy)
boolean
C0015895 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
C0677582 (UMLS CUI [3])
negative pregnancy test
Item
if female, negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
spasticity; Multiple Sclerosis
Item
known history of spasticity due to ms prior to starting baclofen
boolean
C0026838 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
dosage baclofen
Item
a stable daily dose of baclofen ir, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
boolean
C0178602 (UMLS CUI [1,1])
C0004609 (UMLS CUI [1,2])
compliance
Item
able and willing to comply with the protocol, including availability for a scheduled clinic visits
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
willingness and giving of written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity baclofen
Item
history of hypersensitivity to baclofen
boolean
C0020517 (UMLS CUI [1,1])
C0004609 (UMLS CUI [1,2])
disease relapse
Item
in relapse or history of unstable course over the prior 30 days prior to the screening visit
boolean
C0277556 (UMLS CUI [1])
concomitant disease neurologic
Item
concomitant neurologic conditions causing spasticity
boolean
C0243087 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
concomitant medication
Item
has received an investigational drug or device within 30 days that would interfere with the study goals prior to the screening visit
boolean
C2347852 (UMLS CUI [1])
compliance
Item
unable to comply with study procedures in the opinion of the investigator
boolean
C1321605 (UMLS CUI [1])
major surgery
Item
has had major surgery within 3 months prior to screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
boolean
C0679637 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

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