Informações:
Falhas:
ID
43832
Descrição
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
Palavras-chave
Versões (2)
- 13/03/16 13/03/16 -
- 20/09/21 20/09/21 -
Transferido a
20 settembre 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Spasticity NCT01457352
Eligibility Spasticity NCT01457352
- StudyEvent: Eligibility
Similar models
Eligibility Spasticity NCT01457352
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
gender; age
Item
men and women age 18 years and older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
hypersensitivity baclofen
Item
history of hypersensitivity to baclofen
boolean
C0020517 (UMLS CUI [1,1])
C0004609 (UMLS CUI [1,2])
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])
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])