ID

33589

Beschreibung

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains the eligibility criteria of the study. It should be checked at the screening visit and checked by admission. For Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria’s apply The following must all be answered ‘Yes’ for the subject to be eligible to take part in the study For Exclusion Criteria: A subject will not be eligible for inclusion in this study only if any of the following criteria’s apply The following must all be answered ‘No’ for the subject to be eligible to take part in the study Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Stichworte

Versionen (3)
  1. 03.12.18 03.12.18 -
  2. 14.12.18 14.12.18 -
  3. 19.12.18 19.12.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

14. Dezember 2018

DOI

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Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschreibung

Subject Screening No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Right-handed healthy male subjects aged between 18 and 55 years, inclusive.
Beschreibung

Handedness, Gender, Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023114
Body weight >50 kg and Body Mass Index (BMI) within the range 19-29.9 kg/m2 inclusive.
Beschreibung

Body weight, BMI

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
No abnormality on relevant clinical examination.
Beschreibung

A subject with a clinical abnormality may be included only if the Investigator after discussion with the GSK nominated Medical Monitor considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination.
Beschreibung

Subjects with laboratory parameters outside the reference range for this age group will only be included if the Investigator after discussion with the GSK nominated Medical Monitor considers considers that such findings will not introduce additional risk factors.

Datentyp

boolean

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2]
C0018941
A 12-lead ECG at the pre-study medical examination, which is normal.
Beschreibung

Subjects with ECG changes may be acceptable for inclusion in the study if the Investigator after discussion with the GSK nominated Medical Monitor considers considers that such findings will not introduce additional risk factors.

Datentyp

boolean

Alias
UMLS CUI [1]
C0430456
Signed and dated written informed consent prior to admission to the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Normal EEG with photo stimulation
Beschreibung

EEG with Photo Stimulation

Datentyp

boolean

Alias
UMLS CUI [1]
C0430786
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
A positive pre-study Hepatitis B suface antigen, Hepatitis C antibody, and Human Immunodeficiency virus (HIV) antibody result at screening examination.
Beschreibung

Pre-study HepB, HepC and HIV Antibody Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0201487
UMLS CUI [2]
C0201478
UMLS CUI [3]
C2229753
A positive pre-study urine drug test at screening or prior to each treatment period
Beschreibung

Urine Drug Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0202274
A positive alcohol urine drug test at screening or prior to each treatment period.
Beschreibung

Alcohol Urine Drug Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0042036
An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 30 days following administration of the last dose of study medication.
Beschreibung

Unwillingness of Male Subject to Use Condom plus Femal Partner Unwilling to Use Another Form of Contraception, e.g. IUD, Diaphragm with Spermicide, Oral Contraceptives, Injectable Progesterone, Subdermal Implants or Tubal Ligation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706180
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0037862
UMLS CUI [3]
C0009653
UMLS CUI [4,1]
C1705497
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0600109
UMLS CUI [4,4]
C0682323
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0544374
UMLS CUI [9]
C0375850
UMLS CUI [10]
C0520483
History or evidence of drug or alcohol abuse within six months of study start.
Beschreibung

History of Recent Drug or Alcohol Abuse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0085762
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0038586
Weekly alcohol intake of more than 21 units or an average daily intake of greater than three units.
Beschreibung

One unit is equivalent to half pint of beer (220 mL) or one (25 mL) measure of spirits or one glass (125 mL) of wine.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332174
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0332173
Positive pre-study drugs of abuse or alcohol urine test
Beschreibung

Drug and Alcohol Urine Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0202274
UMLS CUI [2,1]
C0202304
UMLS CUI [2,2]
C0042036
Has received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the dosing day, which in the opinion of the Principal/Co-Investigator, may interfere with the study procedures or compromise safety. Paracetamol for mild analgesia will be permitted
Beschreibung

Recent Medication of Prescribed or Non-Prescribed Medication Excluding Paracetamol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C3166216
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C1360419
UMLS CUI [5]
C0003138
UMLS CUI [6,1]
C0000970
UMLS CUI [6,2]
C2828389
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
Beschreibung

Trial Participation with Investigational Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Donation of blood in excess of 500 mL within 3 months prior to the first dose of study medication
Beschreibung

Recent Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
History of hypersensitivity to lamotrigine
Beschreibung

History of Hypersensitivity to Lamotrigine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0064636
History of clinically relevant skin rashes and allergies that, in the opinion of the investigator, might interfere with the conduct of the study.
Beschreibung

History of Skin Rashes and Allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015230
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0020517
Any subject where the potential CNS side effects of GW273225 and lamotrigine could affect their professional occupation, e.g. operating machinery, driving.
Beschreibung

Side Effect Affecting Professional Occupation, Operating Machinery, Driving

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2698884
UMLS CUI [2,1]
C3242339
UMLS CUI [2,2]
C0681590
UMLS CUI [3]
C0004379
Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related), or any condition which, in the opinion of the investigator, predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
Beschreibung

History of Seizure Disorder or Brain Injury, any Condition with Predisposition to Seizure, Treatment with Medications lowering Seizure Threshold or Undergoing Abrupt Discontinuation of Alcohol or Sedatives

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0876926
UMLS CUI [3,1]
C0220898
UMLS CUI [3,2]
C0036572
UMLS CUI [4,1]
C0234976
UMLS CUI [4,2]
C0013227
UMLS CUI [5,1]
C0457454
UMLS CUI [5,2]
C0001948
UMLS CUI [6,1]
C0457454
UMLS CUI [6,2]
C0036557
Poorly-controlled migraine headaches
Beschreibung

Migraine Headaches Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C0205318
Implanted metal devices including pacemakers
Beschreibung

Implanted metal Devices, Pacemakers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C0025552
UMLS CUI [2]
C0810633
Previous brain neurosurgery
Beschreibung

Previous Brain Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0205156
History of neurological disorders and stroke
Beschreibung

History of Neurological Disorders and Stroke

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0038454
Eligibility Review Following Screening
Beschreibung

Eligibility Review Following Screening

Alias
UMLS CUI-1
C0013893
Does the subject satisfy the Inclusion/Exclusion criteria of this study protocol?
Beschreibung

If the answer is No, please give the reason below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C1512693
UMLS CUI [2,1]
C0242428
UMLS CUI [2,2]
C0680251
Comment if the subject did not satisfy the Inclusion/Exclusion criteria of this study protocol?
Beschreibung

Satisfaction of Inclusion/Exclusion Criteria Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C1512693
UMLS CUI [2,1]
C0242428
UMLS CUI [2,2]
C0680251
UMLS CUI [3]
C0947611
Physician's Initials
Beschreibung

Physician's Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Handedness, Gender, Age
Item
Right-handed healthy male subjects aged between 18 and 55 years, inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023114 (UMLS CUI [3])
Body weight, BMI
Item
Body weight >50 kg and Body Mass Index (BMI) within the range 19-29.9 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Clinical Examination
Item
No abnormality on relevant clinical examination.
boolean
C0031809 (UMLS CUI [1])
Clinical Chemistry, Haematology Examination
Item
No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination.
boolean
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
12-lead ECG
Item
A 12-lead ECG at the pre-study medical examination, which is normal.
boolean
C0430456 (UMLS CUI [1])
Informed Consent
Item
Signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
boolean
C0525058 (UMLS CUI [1])
EEG with Photo Stimulation
Item
Normal EEG with photo stimulation
boolean
C0430786 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pre-study HepB, HepC and HIV Antibody Test
Item
A positive pre-study Hepatitis B suface antigen, Hepatitis C antibody, and Human Immunodeficiency virus (HIV) antibody result at screening examination.
boolean
C0201487 (UMLS CUI [1])
C0201478 (UMLS CUI [2])
C2229753 (UMLS CUI [3])
Urine Drug Test
Item
A positive pre-study urine drug test at screening or prior to each treatment period
boolean
C0202274 (UMLS CUI [1])
Alcohol Urine Drug Test
Item
A positive alcohol urine drug test at screening or prior to each treatment period.
boolean
C0202304 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Unwillingness of Male Subject to Use Condom plus Femal Partner Unwilling to Use Another Form of Contraception, e.g. IUD, Diaphragm with Spermicide, Oral Contraceptives, Injectable Progesterone, Subdermal Implants or Tubal Ligation
Item
An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 30 days following administration of the last dose of study medication.
boolean
C1706180 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0037862 (UMLS CUI [2])
C0009653 (UMLS CUI [3])
C1705497 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
C0682323 (UMLS CUI [4,4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0544374 (UMLS CUI [8])
C0375850 (UMLS CUI [9])
C0520483 (UMLS CUI [10])
History of Recent Drug or Alcohol Abuse
Item
History or evidence of drug or alcohol abuse within six months of study start.
boolean
C0262926 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0085762 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2,3])
Weekly And Daily Alcohol Intake
Item
Weekly alcohol intake of more than 21 units or an average daily intake of greater than three units.
boolean
C0001948 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
Drug and Alcohol Urine Test
Item
Positive pre-study drugs of abuse or alcohol urine test
boolean
C0202274 (UMLS CUI [1])
C0202304 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Recent Medication of Prescribed or Non-Prescribed Medication Excluding Paracetamol
Item
Has received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the dosing day, which in the opinion of the Principal/Co-Investigator, may interfere with the study procedures or compromise safety. Paracetamol for mild analgesia will be permitted
boolean
C0332185 (UMLS CUI [1,1])
C3166216 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C1360419 (UMLS CUI [4])
C0003138 (UMLS CUI [5])
C0000970 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
Trial Participation with Investigational Drug
Item
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Recent Blood Donation
Item
Donation of blood in excess of 500 mL within 3 months prior to the first dose of study medication
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of Hypersensitivity to Lamotrigine
Item
History of hypersensitivity to lamotrigine
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
History of Skin Rashes and Allergies
Item
History of clinically relevant skin rashes and allergies that, in the opinion of the investigator, might interfere with the conduct of the study.
boolean
C0262926 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
Side Effect Affecting Professional Occupation, Operating Machinery, Driving
Item
Any subject where the potential CNS side effects of GW273225 and lamotrigine could affect their professional occupation, e.g. operating machinery, driving.
boolean
C0879626 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2698884 (UMLS CUI [1,3])
C3242339 (UMLS CUI [2,1])
C0681590 (UMLS CUI [2,2])
C0004379 (UMLS CUI [3])
History of Seizure Disorder or Brain Injury, any Condition with Predisposition to Seizure, Treatment with Medications lowering Seizure Threshold or Undergoing Abrupt Discontinuation of Alcohol or Sedatives
Item
Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related), or any condition which, in the opinion of the investigator, predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0876926 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0234976 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0457454 (UMLS CUI [5,1])
C0001948 (UMLS CUI [5,2])
C0457454 (UMLS CUI [6,1])
C0036557 (UMLS CUI [6,2])
Migraine Headaches Uncontrolled
Item
Poorly-controlled migraine headaches
boolean
C0149931 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Implanted metal Devices, Pacemakers
Item
Implanted metal devices including pacemakers
boolean
C0025080 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0025552 (UMLS CUI [1,3])
C0810633 (UMLS CUI [2])
Previous Brain Surgery
Item
Previous brain neurosurgery
boolean
C0524850 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
History of Neurological Disorders and Stroke
Item
History of neurological disorders and stroke
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
Item Group
Eligibility Review Following Screening
C0013893 (UMLS CUI-1)
Satisfaction of Inclusion/Exclusion Criteria
Item
Does the subject satisfy the Inclusion/Exclusion criteria of this study protocol?
boolean
C0242428 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0242428 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
Satisfaction of Inclusion/Exclusion Criteria Comment
Item
Comment if the subject did not satisfy the Inclusion/Exclusion criteria of this study protocol?
text
C0242428 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0242428 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Physician's Initials
Item
Physician's Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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