Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Genzyme |
---|---|
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00466635 |
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
Condition | Intervention | Phase |
---|---|---|
Enterocolitis, Pseudomembranous Diarrhea Clostridium Difficile |
Drug: GT267-004 (tolevamer potassium sodium) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Modesto, California, United States | |
United States, Hawaii | |
Honolulu, Hawaii, United States | |
United States, Illinois | |
Maywood, Illinois, United States | |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Worcester, Massachusetts, United States | |
United States, Michigan | |
West Bloomfield, Michigan, United States | |
United States, Montana | |
Butte, Montana, United States | |
United States, New Jersey | |
Neptune, New Jersey, United States | |
Cedar Knolls, New Jersey, United States | |
United States, New York | |
Syracuse, New York, United States | |
United States, North Carolina | |
Greenville, North Carolina, United States | |
United States, Ohio | |
Toledo, Ohio, United States | |
United States, Pennsylvania | |
Lancaster, Pennsylvania, United States |
Study Director: | David Davidson, M.D. | Genzyme |
Study ID Numbers: | TOL26700706 |
Study First Received: | April 25, 2007 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00466635 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Clostridium difficile Disease Infectious diarrhea C. difficile CDAD Clostridium difficile-associated diarrhea Clostridium difficile diarrhea |
Antibiotic-Associated Colitis Clostridium Enterocolitis Antibiotic-Associated Diarrhea Pseudomembranous Colitis Clostridium difficile |
Bacterial Infections Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Clostridium Difficile Enterocolitis, Pseudomembranous Intestinal Diseases Enterocolitis |
Anti-Bacterial Agents Signs and Symptoms Gram-Positive Bacterial Infections Digestive System Diseases Dysentery Gastroenteritis Clostridium Infections Colitis |
Bacterial Infections Signs and Symptoms Gram-Positive Bacterial Infections Digestive System Diseases Diarrhea Signs and Symptoms, Digestive |
Gastrointestinal Diseases Enterocolitis, Pseudomembranous Clostridium Infections Intestinal Diseases Gastroenteritis Enterocolitis |