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Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis

NCT02888379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-07-07

No results posted yet for this study

Summary

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

Conditions

Interventions

DRUG

TOP1288

DRUG

Placebo (for TOP1288)

Sponsors & Collaborators

  • Topivert Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Simon Travis, FRCP · Oxford University Hospitals Trust, John Radcliffe Hospital, Oxford, UK,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-28
Completion
2017-06-28

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02888379 on ClinicalTrials.gov