ID
38930
Beschreibung
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
Stichworte
Versionen (1)
- 14.11.19 14.11.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
14. November 2019
DOI
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Lizenz
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
Beschreibung
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
Beschreibung
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
AST reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Total bilirubin reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Alkaline phosphatase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
5' nucleotidase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Gammaglutamyltranspeptidase reached stopping criteria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Other liver chemistry result reached stopping criteria
Datentyp
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
Beschreibung
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
If yes, ensure Pregnancy Notification Form has been completed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
If Yes, answer whether the results were normal
Datentyp
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
Beschreibung
If applicable lf No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form
Datentyp
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
Beschreibung
If yes, complete Liver Biopsy form.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beschreibung
If yes, record on the appropriate Concomitant Medication form.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschreibung
Recent fasting or significant dietary change
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2826267
Beschreibung
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
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.
Datentyp
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
Beschreibung
If applicable, record date below.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1272460
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
If applicable, record date below.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1272460
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Pharmacokinetics
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
if applicable
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschreibung
if applicable
Datentyp
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
Beschreibung
if applicable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1299222
Beschreibung
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschreibung
Acute type A viral hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0276434
Beschreibung
Hepatitis B, Chronic
Datentyp
text
Alias
- UMLS CUI [1]
- C0524909
Beschreibung
Hepatitis C, Chronic
Datentyp
text
Alias
- UMLS CUI [1]
- C0524910
Beschreibung
Cytomegalovirus Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0276252
Beschreibung
Infectious Mononucleosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0021345
Beschreibung
Herpes Simplex Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C1963747
Beschreibung
Alcoholic Liver Diseases
Datentyp
text
Alias
- UMLS CUI [1]
- C0023896
Beschreibung
Non-alcoholic Steatohepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C3241937
Beschreibung
Fatty Liver
Datentyp
text
Alias
- UMLS CUI [1]
- C0015695
Beschreibung
Hepatic Cirrhosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0023890
Beschreibung
Hemochromatosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0018995
Beschreibung
Autoimmune Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0241910
Beschreibung
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Datentyp
text
Alias
- UMLS CUI [1]
- C0016977
Beschreibung
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beschreibung
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschreibung
Sequence Number
Datentyp
text
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Other liver disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschreibung
Modified Term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Other Liver Disease Conditions - Status
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschreibung
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschreibung
Drug Allergies
Datentyp
text
Alias
- UMLS CUI [1]
- C0013182
Beschreibung
Rheumatoid Arthritis
Datentyp
text
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
Psoriasis
Datentyp
text
Alias
- UMLS CUI [1]
- C0033860
Beschreibung
Thyroid Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0040128
Beschreibung
Inflammatory Bowel Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
Lupus
Datentyp
text
Alias
- UMLS CUI [1]
- C0409974
Beschreibung
Sjogren's Syndrome
Datentyp
text
Alias
- UMLS CUI [1]
- C1527336
Beschreibung
Vitiligo
Datentyp
text
Alias
- UMLS CUI [1]
- C0042900
Beschreibung
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
Beschreibung
If Yes, record the average number of units of alcohol consumed per week
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
if applicable
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Ähnliche Modelle
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])