Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
NCT ID: NCT02933879
Last Updated: 2018-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2016-03-21
2018-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NVXT topical
daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B),
NVXT topical
topical treatment
Placebo (Vehicle) Topical
two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
Placebo (Vehicle) Topical
Placebo (Vehicle) Topical
Interventions
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NVXT topical
topical treatment
Placebo (Vehicle) Topical
Placebo (Vehicle) Topical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Novum Pharmaceutical Research Services
Role: STUDY_CHAIR
http://www.novumprs.com/contact
Locations
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Novum Pharmaceutical Research Services (Novum)
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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NVXT 1404
Identifier Type: -
Identifier Source: org_study_id
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