ID
38930
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00992160
Palabras clave
Versiones (1)
- 14/11/19 14/11/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
14 de noviembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
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
Descripción
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
AST reached stopping criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
Total bilirubin reached stopping criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
Alkaline phosphatase reached stopping criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
5' nucleotidase reached stopping criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
Gammaglutamyltranspeptidase reached stopping criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Descripción
Other liver chemistry result reached stopping criteria
Tipo de datos
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
Descripción
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Descripción
Age
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
If yes, ensure Pregnancy Notification Form has been completed.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032961
Descripción
If Yes, answer whether the results were normal
Tipo de datos
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
Descripción
If applicable lf No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form
Tipo de datos
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
Descripción
If yes, complete Liver Biopsy form.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Descripción
If yes, record on the appropriate Concomitant Medication form.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Descripción
Recent fasting or significant dietary change
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826267
Descripción
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Descripción
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.
Tipo de datos
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
Descripción
If applicable, record date below.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1272460
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
If applicable, record date below.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1272460
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
Pharmacokinetics
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Descripción
if applicable
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Descripción
if applicable
Tipo de datos
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
Descripción
if applicable
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Descripción
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Descripción
Acute type A viral hepatitis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0276434
Descripción
Hepatitis B, Chronic
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0524909
Descripción
Hepatitis C, Chronic
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0524910
Descripción
Cytomegalovirus Hepatitis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0276252
Descripción
Infectious Mononucleosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0021345
Descripción
Herpes Simplex Hepatitis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1963747
Descripción
Alcoholic Liver Diseases
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023896
Descripción
Non-alcoholic Steatohepatitis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3241937
Descripción
Fatty Liver
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0015695
Descripción
Hepatic Cirrhosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0023890
Descripción
Hemochromatosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0018995
Descripción
Autoimmune Hepatitis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0241910
Descripción
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0016977
Descripción
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Descripción
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Descripción
Sequence Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348184
Descripción
Other liver disease
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Descripción
Modified Term
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826302
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3898442
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Other Liver Disease Conditions - Status
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Descripción
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Descripción
Drug Allergies
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013182
Descripción
Rheumatoid Arthritis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0003873
Descripción
Psoriasis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0033860
Descripción
Thyroid Disease
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0040128
Descripción
Inflammatory Bowel Disease
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0021390
Descripción
Lupus
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0409974
Descripción
Sjogren's Syndrome
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1527336
Descripción
Vitiligo
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0042900
Descripción
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
Descripción
If Yes, record the average number of units of alcohol consumed per week
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001948
Descripción
if applicable
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
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Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
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C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
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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])