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

Information source: Summit Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile Infection

Intervention: SMT19969 (Drug); Vancomycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Summit Therapeutics

Official(s) and/or principal investigator(s):
Richard Vickers, PhD, Study Director, Affiliation: Summit (Oxford) Limited

Overall contact:
Evan R Hempel, Phone: 617-401-2474, Email: Codify@summitplc.com

Summary

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).

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the clinical outcome by assessment of sustained clinical response

Secondary outcome:

Plasma and faecal concentrations of SMT19969

To assess the safety and tolerability of SMT19969 compared with vancomycin

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Evan R Hempel, Phone: 617-401-2474, Email: Codify@summitplc.com

Mobile, Alabama, United States; Recruiting

Calgary, Alberta, Canada; Not yet recruiting

Laguna Hills, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Sylmar, California, United States; Recruiting

Ventura, California, United States; Recruiting

Idaho Falls, Idaho, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Topeka, Kansas, United States; Recruiting

Baltimore, Maryland, United States; Recruiting

Boston, Massachusetts, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Novi, Michigan, United States; Withdrawn

Duluth, Minnesota, United States; Recruiting

Minneapolis, Minnesota, United States; Recruiting

Tupelo, Mississippi, United States; Active, not recruiting

Billings, Montana, United States; Recruiting

Butte, Montana, United States; Recruiting

Sommers Point, New Jersey, United States; Recruiting

Bronx, New York, United States; Withdrawn

Rochester, New York, United States; Recruiting

Akron, Ohio, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Columbus, Ohio, United States; Recruiting

Lima, Ohio, United States; Recruiting

Hamilton, Ontario, Canada; Recruiting

Montreal, Quebec, Canada; Recruiting

Rapid City, South Dakota, United States; Recruiting

Seattle, Washington, United States; Recruiting

Additional Information

Starting date: April 2014
Last updated: August 11, 2015

Page last updated: August 23, 2015

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