ID
30546
Beskrivning
This ODM file contains Eligibility Criteria. To be filled in at Screening. Do an Inclusion/Exclusion Check at Sessions 1 and 2 (Day -1). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
Länk
https://clinicaltrials.gov/ct2/show/NCT01039454
Nyckelord
Versioner (1)
- 2018-06-13 2018-06-13 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
13 juni 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454
Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beskrivning
To be answered at screening. If No, fill in the items of Inclusion and Exclusion criteria. Answer "no" corresponding to violations of any inclusion criteria, "yes" corresponding to violations of any Exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.
Datatyp
text
Alias
- UMLS CUI [1]
- C1302261
Beskrivning
Inclusion/Exclusion Criteria Check
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to compromise subject safety or interfere with study integrity. Subjects with elevated prolactin values outside the normal range should always be excluded from enrollment.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1708335
- UMLS CUI [2,1]
- C0373706
- UMLS CUI [2,2]
- C0205307
Beskrivning
Selected to encompass subjects without significant chance of brain function decline due to age.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Beskrivning
Referral to dietician
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0420347
Beskrivning
a requirement to ensure consistency of fMRI signals from the brain
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344333
Beskrivning
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) will not be included in the study. Child-bearing potential and agrees to use one of the contraception methods listed for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 90 days after completion of the study. If female subjects are currently using oral or depot hormonal contraceptives, they may be enrolled but must also use one other form of contraception as listed. List of contraceptive methods with failure rate below 1 percent: * Abstinence: Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Intrauterine device (IUD) or intrauterine system (IUS) that meets the under 1 percent failure rate as stated in the product label. * Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. * Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3831118
- UMLS CUI [2]
- C0700589
Beskrivning
This criterion must be followed from the time of the first dose of study medication until 90 days after completion of the study. List: * Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Double barrier method: condom plus spermicidal agent (foam/gel/film/cream/suppository).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0086580
Beskrivning
BMI 27-40, comfortable body habitus
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2,1]
- C1318474
- UMLS CUI [2,2]
- C1331418
Beskrivning
(Capable of) Written informed consent, Compliance with study requirements
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2698977
- UMLS CUI [2,1]
- C0525058
- UMLS CUI [2,2]
- C2698977
Beskrivning
QTcB or QTcF < 450 msec.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882512
- UMLS CUI [2]
- C1882513
Beskrivning
Beck Depression Inventory II < 13, Suicide question score = 0
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4273555
- UMLS CUI [2,1]
- C0038661
- UMLS CUI [2,2]
- C0681889
Beskrivning
Binge eating
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0596170
Beskrivning
TFEQ-R18 (Q3, Q6 and/or Q10 at least 3)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0013473
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric diseases or endocrine disease.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0392760
- UMLS CUI [1,3]
- C0459471
Beskrivning
(with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).
Datatyp
text
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0920548
Beskrivning
closed angle glaucoma
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0017605
Beskrivning
prostatic hyperplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2937421
Beskrivning
e.g. pacemaker, hearing aid, tattoos, metallic body piercing and/or other metal implants that cannot be removed.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0024485
- UMLS CUI [1,2]
- C0522473
Beskrivning
Examples of such include, but are not limited to: schizophrenia or psychosis, major depressive disorder, anxiety disorders, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, rheumatoid arthritis and fibromyalgia syndrome.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0024485
- UMLS CUI [1,3]
- C0004936
- UMLS CUI [1,4]
- C0024485
- UMLS CUI [1,5]
- C4054723
- UMLS CUI [2,1]
- C0027765
- UMLS CUI [2,2]
- C0024485
- UMLS CUI [2,3]
- C4054723
Beskrivning
Anorexia nervosa, Bulimia nervosa, Binge eating without obesity
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0003125
- UMLS CUI [2]
- C2267227
- UMLS CUI [3,1]
- C0596170
- UMLS CUI [3,2]
- C0028754
- UMLS CUI [3,3]
- C1298908
Beskrivning
Weight loss or gain > 5 percent in last 3 months
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005911
Beskrivning
obesity surgery
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2112820
Beskrivning
Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085762
- UMLS CUI [2]
- C0038586
- UMLS CUI [3]
- C0038580
- UMLS CUI [4]
- C0740866
Beskrivning
Cotinine levels, History of smoking
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519384
- UMLS CUI [2]
- C0202363
Beskrivning
Drug screen positive
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0743300
Beskrivning
Subjects above this limit may only be included if direct bilirubin is within normal limits, which would be consistent with Gilbert’s disease.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1278039
- UMLS CUI [2]
- C0201899
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0582824
Beskrivning
Lipid-lowering therapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0585943
Beskrivning
Diabetes mellitus Type 1/2, fasting plasma glucose, oral glycemic agent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011860
- UMLS CUI [2]
- C0011854
- UMLS CUI [3]
- C0583513
- UMLS CUI [4]
- C0421247
Beskrivning
Systolic or diastolic blood pressure above/below limits
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
Beskrivning
Female subjects who are taking an oral contraceptive preparation at the time of screening may be eligible for enrolment in the study, however they must use additional forms of contraception.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009905
- UMLS CUI [2]
- C3274784
- UMLS CUI [3]
- C3274784
- UMLS CUI [4]
- C0850893
Beskrivning
current or planned pregnancy, hCG test
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0546577
- UMLS CUI [2]
- C0032992
Beskrivning
Lactating
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2828358
Beskrivning
* use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication with the exception of occasional non-daily use of acetaminophen, or non-steroidal anti-inflammatory agents. * Use of weight loss drugs within three months of the first dose of the marketed drug. * Use of any oral anti-diabetic medication (including metformin, sulphonylureas, thiazolidinedione, GLP-1 agonist, DDP-IV inhibitors). * Use of antidepressants or anxiolytics (selective serotonin re-uptake inhibitor (SSRI), tricyclic, buprion, sedatives, hypnotics) on any basis other than occasional within 6 months of screening. * Use of antipsychotics (i.e. D2 antagonists) or any dopamine agonists (i.e. bromocriptine, pergolide) or Parkinson’s disease medications (L-DOPA) ever * Use of diuretics, systemic corticosteroids (inhaled and intranasal corticosteroids are permitted), or any other medication within 3 weeks prior to any scheduled dose of study medication that may result in electrolyte depletion. * Use of macrolide antibiotics during the interventional part of the study. Medications not allowed: At least 6 months prior to the Baseline Visit: All antidepressants, Lithium At least 2 weeks prior to Baseline visit (or 5 half-lives whichever is longer): Psychoactive herbal or nutritional treatment (e.g., St. John's Wort, SAM-e), Opiates, hypnotics, anxiolytics, and all other sedatives (including as needed benzodiazepines as sleep aids), Systemic corticosteroids (NOTE: Topical hydrocortisone, inhaled and nasal corticosteroids are allowed). Concomitant medications that are known potent or moderate inducers or inhibitors of CYP3A4/5 for 14 days prior to administration randomization through 14 days after the last dose of investigational product: CYP3A4/5 Inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil (Intermittent use of topical/vaginal antifungal medications are permitted), CYP3A4/5 Inducers: carbamazepine, phenobarbitol, phenytoin, rifabutin, rifampicin, St John’s Wort. Please note that this is not an exhaustive list.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Investigational drug or device in last 12 months
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C2346570
Beskrivning
Sensitivity to study medication, other (drug) allergy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0013182
- UMLS CUI [3]
- C0020517
Beskrivning
Study participation resulting in Blood donation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005794
- UMLS CUI [1,2]
- C2348568
Beskrivning
Red wine, seville oranges, grapefruit (juice)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0995150
- UMLS CUI [2]
- C0452456
- UMLS CUI [3]
- C0349371
- UMLS CUI [4]
- C0330922
Beskrivning
Serum Prolactin
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0373706
Beskrivning
DSM-IV Axis I or II
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0270287
- UMLS CUI [1,2]
- C0220952
- UMLS CUI [2,1]
- C0270288
- UMLS CUI [2,2]
- C0220952
- UMLS CUI [3]
- C0596170
Beskrivning
QTc prolonged, arrhythmia, sudden unexplained death/syncope in first degree relative
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1969409
- UMLS CUI [2,1]
- C0011071
- UMLS CUI [2,2]
- C1517194
- UMLS CUI [3,1]
- C1517194
- UMLS CUI [3,2]
- C0039070
- UMLS CUI [4]
- C0003811
Beskrivning
Protocol compliance unwilling/unable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [2,1]
- C0525058
- UMLS CUI [2,2]
- C1299582
Beskrivning
Healthy food preference
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016483
- UMLS CUI [1,2]
- C3898900
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0373706 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0001779 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
C1318474 (UMLS CUI [2,1])
C1331418 (UMLS CUI [2,2])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C1882513 (UMLS CUI [2])
C0038661 (UMLS CUI [2,1])
C0681889 (UMLS CUI [2,2])
C0013473 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
C0522473 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C4054723 (UMLS CUI [1,5])
C0027765 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C4054723 (UMLS CUI [2,3])
C2267227 (UMLS CUI [2])
C0596170 (UMLS CUI [3,1])
C0028754 (UMLS CUI [3,2])
C1298908 (UMLS CUI [3,3])
C0038586 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0740866 (UMLS CUI [4])
C0202363 (UMLS CUI [2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0582824 (UMLS CUI [4])
C0011854 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0421247 (UMLS CUI [4])
C0428883 (UMLS CUI [2])
C3274784 (UMLS CUI [2])
C3274784 (UMLS CUI [3])
C0850893 (UMLS CUI [4])
C0546577 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C2346570 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
C2348568 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2])
C0349371 (UMLS CUI [3])
C0330922 (UMLS CUI [4])
C0220952 (UMLS CUI [1,2])
C0270288 (UMLS CUI [2,1])
C0220952 (UMLS CUI [2,2])
C0596170 (UMLS CUI [3])
C0011071 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C0039070 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C3898900 (UMLS CUI [1,2])
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