ID
39941
Description
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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Mots-clés
Versions (2)
- 04/03/2020 04/03/2020 -
- 05/03/2020 05/03/2020 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
5 mars 2020
DOI
Pour une demande vous connecter.
Licence
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
Description
In case of emergency, please contact:
Alias
- UMLS CUI-1
- C0013956
- UMLS CUI-2
- C0332158
Description
Investigator
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Study contact
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332158
- UMLS CUI [1,2]
- C0008976
Description
Telephone (daytime)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0332169
Description
Telephone (evening/weekends)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0587117
- UMLS CUI [2,1]
- C1515258
- UMLS CUI [2,2]
- C0680190
Description
Address
Type de données
text
Alias
- UMLS CUI [1]
- C1442065
Description
Diary card
Alias
- UMLS CUI-1
- C3890583
Description
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.
Type de données
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
Description
Study drug
Alias
- UMLS CUI-1
- C0304229
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Description
Other dosing day
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0304229
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0039225
- UMLS CUI [1,3]
- C0179376
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0039225
- UMLS CUI [1,3]
- C0179376
Description
Exacerbations
Alias
- UMLS CUI-1
- C4086268
Description
CF Exacerbation event, record.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C4086268
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C0332127
Description
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.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0010674
- UMLS CUI [1,3]
- C4086268
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C2699488
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
If Yes, record each antibiotic in the itemgroup OTHER MEDICATIONS.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0003232
- UMLS CUI [1,2]
- C0033080
- UMLS CUI [1,3]
- C0010674
- UMLS CUI [1,4]
- C4086268
Description
Exacerbation of CF requiring hospitalisation
Type de données
text
Alias
- UMLS CUI [1,1]
- C0010674
- UMLS CUI [1,2]
- C4086268
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [1,4]
- C0019993
Description
Other medications
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0013227
Description
Medication record
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332127
Description
e.g., Aspirin
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
e.g., Tablet
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0013227
Description
Amount Taken of medication
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1265611
- UMLS CUI [1,2]
- C0013227
Description
e.g., Headache
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1301880
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1522314
Description
Changes in health
Alias
- UMLS CUI-1
- C0392747
- UMLS CUI-2
- C0018759
Description
Changes in health, record.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0392747
- UMLS CUI [1,2]
- C0018759
- UMLS CUI [1,3]
- C0332127
Description
Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Headache
Type de données
text
Alias
- UMLS CUI [1]
- C0441471
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0808070
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1301880
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0806020
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C1522314
Description
Maximum intensity of event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0518690
Description
Daily Respiratory Symptom Diary for Cystic Fibrosis
Alias
- UMLS CUI-1
- C0034394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0010674
- UMLS CUI-4
- C0332173
Description
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.
Type de données
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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