ID
39941
Beschrijving
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Subject Diary Card form. It has to be filled in at day 2-13, day 15-20 and day 22-27.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Trefwoorden
Versies (2)
- 04-03-20 04-03-20 -
- 05-03-20 05-03-20 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 maart 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Subject Diary Card
- StudyEvent: ODM
Beschrijving
In case of emergency, please contact:
Alias
- UMLS CUI-1
- C0013956
- UMLS CUI-2
- C0332158
Beschrijving
Investigator
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Study contact
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332158
- UMLS CUI [1,2]
- C0008976
Beschrijving
Telephone (daytime)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0332169
Beschrijving
Telephone (evening/weekends)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0587117
- UMLS CUI [2,1]
- C1515258
- UMLS CUI [2,2]
- C0680190
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1]
- C1442065
Beschrijving
Diary card
Alias
- UMLS CUI-1
- C3890583
Beschrijving
Note: Please complete the web based diary (questionnaire) daily in the evenings. Note: Day 1 will be dosed in the unit. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0010674
- UMLS CUI [1,2]
- C3890583
- UMLS CUI [1,3]
- C0159028
- UMLS CUI [1,4]
- C2349146
- UMLS CUI [1,5]
- C1514821
Beschrijving
Study drug
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Note: Do not take bronchodilator prior to clinic visit on Day 14, 21 and 28. Do not perform strenuous exercise 48 hr prior to visit on Day 14, 21 and 28.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Beschrijving
Other dosing day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0304229
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Beschrijving
e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0039225
- UMLS CUI [1,3]
- C0179376
Beschrijving
e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0039225
- UMLS CUI [1,3]
- C0179376
Beschrijving
Exacerbations
Alias
- UMLS CUI-1
- C4086268
Beschrijving
CF Exacerbation event, record.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C4086268
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C0332127
Beschrijving
day month year. Note: If you have an exacerbation, immediately contact the site using the details above. Note: Record your individual symptoms in the itemgroup CHANGES IN HEALTH.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beschrijving
If Yes, record each antibiotic in the itemgroup OTHER MEDICATIONS.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003232
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Beschrijving
Exacerbation of CF requiring hospitalisation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0010674
- UMLS CUI [1,2]
- C4086268
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [1,4]
- C0019993
Beschrijving
Other medications
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0013227
Beschrijving
Medication record
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332127
Beschrijving
e.g., Aspirin
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
e.g., Tablet
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Beschrijving
Amount Taken of medication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1265611
- UMLS CUI [1,2]
- C0013227
Beschrijving
e.g., Headache
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1301880
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1522314
Beschrijving
Changes in health
Alias
- UMLS CUI-1
- C0392747
- UMLS CUI-2
- C0018759
Beschrijving
Changes in health, record.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392747
- UMLS CUI [1,2]
- C0018759
- UMLS CUI [1,3]
- C0332127
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Headache
Datatype
text
Alias
- UMLS CUI [1]
- C0441471
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0808070
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1301880
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0806020
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1522314
Beschrijving
Maximum intensity of event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0518690
Beschrijving
Daily Respiratory Symptom Diary for Cystic Fibrosis
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0010674
- UMLS CUI-4
- C0332173
Beschrijving
This item contains the result of clinical outcome assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0034394
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0010674
- UMLS CUI [1,5]
- C0332173
Similar models
Subject Diary Card
- StudyEvent: ODM
C0332158 (UMLS CUI-2)
C0008976 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
C1515258 (UMLS CUI [2,1])
C0680190 (UMLS CUI [2,2])
C3890583 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C2349146 (UMLS CUI [1,4])
C1514821 (UMLS CUI [1,5])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0039225 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
C0039225 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,2])
C0332127 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C0033080 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
C4086268 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,4])
C0332127 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0018759 (UMLS CUI [1,2])
C0332127 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0010674 (UMLS CUI-3)
C0332173 (UMLS CUI-4)
C0034394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,4])
C0332173 (UMLS CUI [1,5])
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