A Study of GT160-246 Versus Vancomycin in Patients With C... | NCT00034294

Studies
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

NCT00034294

Sponsor

Genzyme, a Sanofi Company

Status

Completed

Last Update Posted

Mar 5, 2015Estimated

Enrollment

300

Phase

Phase 2

Conditions

Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-associated Colitis
Antibiotic-associated Diarrhea

Interventions

GT160-246

Countries

United States
Canada
Puerto Rico
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
GT1105

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Jul 2003Actual

First Submitted Date

Apr 24, 2002

First Submission Date that Met QC Criteria

Apr 24, 2002

First Posted Date

Apr 25, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Description Module

Brief Summary

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.

All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.

Detailed Description

Not provided

Conditions Module

Conditions

Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-associated Colitis
Antibiotic-associated Diarrhea

Keywords

C. difficile-associated diarrhea
CDAD
Clostridium difficile-Associated Diarrhea
Clostridium enterocolitis
antibiotic-associated diarrhea
clostridium difficile colitis
infectious diarrhea
chronic diarrhea
antibiotic-associated colitis

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
GT160-246	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be at least 18 years old.
Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
Be able to tolerate oral medication.
Not be pregnant or breast-feeding.
Sign and date an informed consent form.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Ancestor Terms

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D004760	Enterocolitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36617	United States

ID	Term
D004761	Enterocolitis, Pseudomembranous
D004403	Dysentery