Clinical TrialID 5397
Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
NCT01762787
Inflammation
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5397
- Evidence Id
- 5397
- Core Evidence Id
- 5397
- Source Clinical Trial Id
- 5382
- Herb2 Clinical Trial Id
- HBCT005382
- Nct Id
- NCT01762787
- Title
- Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Inflammation
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
- Intervention
- DRUG: Cantharidin solution|DRUG: Aspirin|DRUG: Prednisolone|DRUG: Placebo to aspirin|DRUG: Placebo to prednisolone
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Single
- Intervention Purpose
- Other
- Gender
- Male
- Age
- Adult
- Enrollment
- 40
- Outcome Measure
- Blister volume of fluid, Volume of fluid extracted from blisters induced by cantharidin application, 48 hours|Cell population in blister fluid, Flow cytometry performed on cells from blister fluid including measurement of some or all of the following parameters: CD45, CD16, CD14, cell viability, CD206, CD64 or CD84, apoptosis, total blister leukocytes (CD45+), monocytes (CD14+), neutrophils (CD16 high), monocyte/macrophage like cells (CD64+ or CD84+); subsets of these cells that are undergoing apoptosis; subsets of monocyte/macrophages, 48 hours|Inflammatory mediators in blister fluid, Inflammatory mediators in blister fluid, measured by immunoassay as primary endpoints may include (but will not be limited to): MPO, IL-10, IL-8, IL-6, IL-1β, TNF-α, LTB4., 48 hours
- Sponsor Collaborator
- GlaxoSmithKline
- Funded By
- INDUSTRY
- Location
- GSK Investigational Site, Cambridge, CB2 2GG, United Kingdom
- Other Id
- 114416
- Start Date
- 2010-08-17
- Primary Completion Date
- 2011-01-14
- Completion Date
- 2011-01-14
- First Posted
- 2013-01-08
- Results First Posted
- Last Update Posted
- 2017-06-28
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01762787
- Title Cn
- Title En
- Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers
- Bilingual Status
- semi_complete