Informações:
Falhas:
ID
35618
Descrição
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis
Palavras-chave
Versões (1)
- 12/03/2019 12/03/2019 -
Titular dos direitos
GSK group of companies
Transferido a
12 de março de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
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Follow-Up
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of Visit
Item
Date of Visit
date
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
Date Blind Broken
Item
Date blind broken
date
CL Item
medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (2)
Specify Other
Item
If Other, please specify
text
Date of completion or withdrawal
Item
Date of subject completion or withdrawal
date
subject withdrawal
Item
Was the subject withdrawn from the study?
boolean
CL Item
Adverse Event (1)
CL Item
Protocol Violation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed / terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion (6)
CL Item
Withdrew consent (7)
Investigator discretion, specify
Item
If Investigator discretion, specify
text
Pregnancy during the Study
Item
Did the subject become pregnant during the study?
boolean
Item
Did a female partner of the male subject become pregnant during the study?
text
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not Applicable (if female partner not of childbearing potential or no female partner) (3)
Item Group
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Concomitant Medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Serious Adverse Events
Item
Did the subject experience any serious adverse events during the study?
boolean
Clinically Significant ECG Measurements
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
Repeat Hematology/ Clinical Chemistry
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
Repeat ECGs
Item
Were any repeat ECGs performed?
boolean
Repeat Vital Signs / Temperature
Item
Were any repeat vital signs or temperature measurements recorded?
boolean
Repeat PK Blood Samples
Item
Were any repeat PK blood samples taken?
boolean
Repeat Peak Nasal Inspiratory Flow Tests
Item
Were any repeat Peak Nasal Inspiratory Flow tests performed?
boolean
Event Number
Item
Event Number
integer
Event Description
Item
Event Description
text
Start Date and Time
Item
Start Date and Time
datetime
End Date and Time
Item
End Date and Time
datetime
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Single episode (1)
CL Item
Intermittent (2)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Subject Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
Causality
Item
Is there a reasonable possibility tha the AE may have been caused by the investigational product?
boolean
SAE Number
Item
SAE Number
integer
SAE Description
Item
Serious Adverse Event Description
text
Start Date and Time
Item
Start Date and Time
datetime
End Date and Time
Item
End Date and Time
datetime
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Subject Withdrawn
Item
Did the subject withdraw from the study as a result of this SAE?
boolean
Causality
Item
Is there a reasonable possibility tha the AE may have been caused by the investigational product?
boolean
Was SAE study related?
Item
Was SAE cause by activities related to study participation(e.g. procedures)?
boolean
Seriousness of Event
Item
Was the event serious
boolean
CL Item
results in death (1)
CL Item
is life-threatening (2)
CL Item
requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
Other (6)
Specify Other
Item
If Other, please specify
text
SAE Occurrence after study initiation
Item
Did SAE occur after initiation of study medication?
boolean
CL Item
Initial (1)
CL Item
Follow-Up (2)
Drug/Medication sequence number
Item
Drug/Medication sequence number
integer
Drug Name
Item
Drug Name
text
Dose
Item
Dose
text
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International Units (9)
CL Item
International Units per kilogram (10)
CL Item
International Units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
lozenge (14)
CL Item
Megaunits (million units) (15)
CL Item
Megaunits (MCG) (16)
CL Item
Megaunits (UG) (17)
CL Item
Microgram/kilogram (18)
CL Item
Microgram/kilogram per minute (19)
CL Item
Migrograms per minute (20)
CL Item
Microlitre (21)
CL Item
Milliequvalent (22)
CL Item
Milliequvalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent (25)
CL Item
Milligram per hour (26)
CL Item
Milligram/kilogram (27)
CL Item
Milligram/kilogram per hour (28)
CL Item
Milligram/kilogram per minute (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre (31)
CL Item
Millilitre (32)
CL Item
Millilitre per hour (33)
CL Item
Millilitre per minute (34)
CL Item
Millimole (35)
CL Item
Million international units (36)
CL Item
Minimum alveolar concentration (37)
CL Item
Nebule (38)
CL Item
Patch (39)
CL Item
Percent (40)
CL Item
Puff (41)
CL Item
Sachet (42)
CL Item
Spray (43)
CL Item
Suppository (44)
CL Item
Tablespoon (45)
CL Item
Tablet (46)
CL Item
Teaspoon (47)
CL Item
Units (48)
CL Item
Unknown (49)
CL Item
Vial (50)
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continuous infusion (8)
CL Item
Every 2 weeks (9)
CL Item
Every 3 weeks (10)
CL Item
Every 3 months (11)
CL Item
Every other day (12)
CL Item
At bedtime (13)
CL Item
Once a month (14)
CL Item
Once a week (15)
CL Item
Once daily (16)
CL Item
Once only (17)
CL Item
PC (18)
CL Item
PRN (19)
CL Item
Q2H (20)
CL Item
Q3D (21)
CL Item
Q4D (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH (28)
CL Item
QID (29)
CL Item
QPM (30)
CL Item
TIO (31)
CL Item
Unknown (32)
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra-arterial (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Intraocular (11)
CL Item
Intraosteal (12)
CL Item
Intraperitoneal (13)
CL Item
Intrathecal (14)
CL Item
Intrauterine (15)
CL Item
Intravenous (16)
CL Item
Nasal (17)
CL Item
Oral (18)
CL Item
Rectal (19)
CL Item
Subcutaneous (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Start Date
Item
Start Date
date
Ongoing?
Item
Ongoing?
boolean
Primary Indication
Item
Primary Indication
text
Condition number
Item
Condition number
integer
Specific Condition Name
Item
Specific Condition Name
text
Start Date
Item
Date of onset
date
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
End Date
Item
Date of last occurrence
date
Medical History
Item
Relevant Medical History / Risk Factors not noted above
text
Lab sequence number
Item
Lab sequence number
integer
CL Item
Activated partical tromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood Pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 Lymphocytes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erithrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamma-glutamyltransferase (31)
CL Item
Glutamic-oxaloacetic transaminase (32)
CL Item
Glutamic-pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV-DNA decreased (35)
CL Item
HBV-DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular hemoglobin (49)
CL Item
Mean corpuscular volume (50)
CL Item
Monocytes (51)
CL Item
Neutrophils (52)
CL Item
Oxygen saturation (53)
CL Item
pCO2 (54)
CL Item
pH (55)
CL Item
Phosphate (56)
CL Item
Palatelet count (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin 1 (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
Test Unit
Item
Test Unit
date
Comment
Item
Comment
text
Item
If investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
Code List
If investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
General narrative comments
Item
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical condition) and details of the treatment.
text
General Narrative Comments
Item
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical condition) and details of the treatment.
text