Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

NCT ID: NCT02933879

Last Updated: 2018-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2018-06-21

Brief Summary

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A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Detailed Description

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Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Conditions

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Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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),

Group Type EXPERIMENTAL

NVXT topical

Intervention Type DRUG

topical treatment

Placebo (Vehicle) Topical

two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),

Group Type PLACEBO_COMPARATOR

Placebo (Vehicle) Topical

Intervention Type DRUG

Placebo (Vehicle) Topical

Interventions

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NVXT topical

topical treatment

Intervention Type DRUG

Placebo (Vehicle) Topical

Placebo (Vehicle) Topical

Intervention Type DRUG

Other Intervention Names

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Active placebo

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).

Exclusion Criteria

* Females who are pregnant, lactating or likely to become pregnant during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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NVXT 1404

Identifier Type: -

Identifier Source: org_study_id

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