ID
38930
Description
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.
Lien
https://clinicaltrials.gov/ct2/show/NCT00992160
Mots-clés
Versions (1)
- 14/11/2019 14/11/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 novembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C2746065
- UMLS CUI-5
- C0243161
Description
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
AST reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Total bilirubin reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Alkaline phosphatase reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
5' nucleotidase reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Gammaglutamyltranspeptidase reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Other liver chemistry result reached stopping criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0008000
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Description
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Description
Age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If yes, ensure Pregnancy Notification Form has been completed.
Type de données
text
Alias
- UMLS CUI [1]
- C0032961
Description
If Yes, answer whether the results were normal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C0412534
- UMLS CUI [4]
- C0412620
- UMLS CUI [5]
- C0412693
- UMLS CUI [6]
- C0008310
Description
If applicable lf No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0456984
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C0023884
Description
If yes, complete Liver Biopsy form.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Description
If yes, record on the appropriate Concomitant Medication form.
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Description
Recent fasting or significant dietary change
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1]
- C2826267
Description
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. Fill in entire itemgroup for both options, chosing "Not applicable" for the dates not required.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0439564
- UMLS CUI [1,5]
- C2347804
Description
If applicable, record date below.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1272460
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
If applicable, record date below.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1272460
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Pharmacokinetics
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Description
An unscheduled PK sample must be obtained within 24-36 hours of last dose. If yes, record date and time sample taken, date and time of last investigational product dose prior to PK sample, and Sample Identifier
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
if applicable
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Description
if applicable
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0945778
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Description
if applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Description
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Description
Acute type A viral hepatitis
Type de données
text
Alias
- UMLS CUI [1]
- C0276434
Description
Hepatitis B, Chronic
Type de données
text
Alias
- UMLS CUI [1]
- C0524909
Description
Hepatitis C, Chronic
Type de données
text
Alias
- UMLS CUI [1]
- C0524910
Description
Cytomegalovirus Hepatitis
Type de données
text
Alias
- UMLS CUI [1]
- C0276252
Description
Infectious Mononucleosis
Type de données
text
Alias
- UMLS CUI [1]
- C0021345
Description
Herpes Simplex Hepatitis
Type de données
text
Alias
- UMLS CUI [1]
- C1963747
Description
Alcoholic Liver Diseases
Type de données
text
Alias
- UMLS CUI [1]
- C0023896
Description
Non-alcoholic Steatohepatitis
Type de données
text
Alias
- UMLS CUI [1]
- C3241937
Description
Fatty Liver
Type de données
text
Alias
- UMLS CUI [1]
- C0015695
Description
Hepatic Cirrhosis
Type de données
text
Alias
- UMLS CUI [1]
- C0023890
Description
Hemochromatosis
Type de données
text
Alias
- UMLS CUI [1]
- C0018995
Description
Autoimmune Hepatitis
Type de données
text
Alias
- UMLS CUI [1]
- C0241910
Description
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Type de données
text
Alias
- UMLS CUI [1]
- C0016977
Description
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Description
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
Sequence Number
Type de données
text
Alias
- UMLS CUI [1]
- C2348184
Description
Other liver disease
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Description
Modified Term
Type de données
text
Alias
- UMLS CUI [1]
- C2826302
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1]
- C3898442
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Other Liver Disease Conditions - Status
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Drug Allergies
Type de données
text
Alias
- UMLS CUI [1]
- C0013182
Description
Rheumatoid Arthritis
Type de données
text
Alias
- UMLS CUI [1]
- C0003873
Description
Psoriasis
Type de données
text
Alias
- UMLS CUI [1]
- C0033860
Description
Thyroid Disease
Type de données
text
Alias
- UMLS CUI [1]
- C0040128
Description
Inflammatory Bowel Disease
Type de données
text
Alias
- UMLS CUI [1]
- C0021390
Description
Lupus
Type de données
text
Alias
- UMLS CUI [1]
- C0409974
Description
Sjogren's Syndrome
Type de données
text
Alias
- UMLS CUI [1]
- C1527336
Description
Vitiligo
Type de données
text
Alias
- UMLS CUI [1]
- C0042900
Description
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
Description
If Yes, record the average number of units of alcohol consumed per week
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
if applicable
Type de données
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Description
[hidden]
Type de données
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Similar models
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0008000 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2746065 (UMLS CUI-4)
C0243161 (UMLS CUI-5)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C1272695 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0031328 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0041755 (UMLS CUI-2)
C0041755 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])