A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

October 19, 2016 updated by: Summit Therapeutics

A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • California
      • Laguna Hills, California, United States
      • Long Beach, California, United States
      • Sylmar, California, United States
      • Ventura, California, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Topeka, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Montana
      • Billings, Montana, United States
      • Butte, Montana, United States
    • New Jersey
      • Sommers Point, New Jersey, United States
    • New York
      • Rochester, New York, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Lima, Ohio, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Clinical diagnosis of CDAD plus laboratory diagnostic test
  • No more than 24 hrs antimicrobial treatment for current CDAD episode
  • No more than 3 episodes of CDAD in prior 12 months
  • No previous episode of CDAD within 30 days of study enrollment
  • Female subjects of childbearing potential must use adequate contraception

Exclusion Criteria:

  • Life-threatening or fulminant colitis
  • Concurrent use of antibiotics or any other treatments for CDAD
  • History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
  • Participation in other Clinical research studies within one month of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMT19969
200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day
Drug: SMT19969
Active Comparator: Vancomycin
125 mg capsule four times a day for 10 days
Drug: Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the clinical outcome by assessment of sustained clinical response
Time Frame: 30 days post End of Therapy
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
30 days post End of Therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma and faecal concentrations of SMT19969
Time Frame: 40 Days
Using laboratory analysis
40 Days
To assess the safety and tolerability of SMT19969 compared with vancomycin
Time Frame: 40 days
Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study
40 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects
Time Frame: 40 days
Using microbiology, sequencing, metagenomic and bioinformatics techniques.
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summit Therapeutics

Collaborators

Wellcome Trust

Investigators

  • Study Director: Richard Vickers, PhD, Summit (Oxford) Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMT19969/C002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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