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