Assignment 4 Celtaxsys

Brief Summary:

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.


Cystic FibrosisDrug: CTX-4430Drug: PlaceboPhase 2

Detailed Description:

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF. A total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every 4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment :200 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title:A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis
Study Start Date :October 2015
Estimated Primary Completion Date :May 2018
Estimated Study Completion Date :June 2018

Brief Summary:

A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.


Acne VulgarisDrug: CTX-4430Drug: PlaceboPhase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment :124 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title:A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
Study Start Date :April 2015
Primary Completion Date :May 2016
Study Completion Date :August 2016

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