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Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

NCT02808390 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-11-27

Study results available
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Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

Conditions

Interventions

DRUG

GED-0507-34-Levo 80 mg

GED-0507-34-Levo 80 mg BID for 8 Weeks

DRUG

GED-0507-34-Levo 160 mg

GED-0507-34-Levo 160 mg BID for 8 Weeks

DRUG

Placebo

Placebo BID for 8 Weeks

Sponsors & Collaborators

  • PPM Services S.A.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Slovakia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808390 on ClinicalTrials.gov