Clinical Trials Logo
  1. Home
  2. Antibiotic-associated Diarrhea
  3. NCT00382304
  4. Details
NCT00382304 Clinical Trial

A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Antibiotic-Associated Diarrhea Clinical Trial

Official title:
A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00382304
Other study ID # TOL26700606
Secondary ID
Status Completed
Phase Phase 2
First received September 27, 2006
Last updated March 17, 2015
Start date September 2006
Est. completion date September 2007

Study information
Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria:

- > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD

- Patient not considered sufficiently stable clinically to complete the study period

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tolevamer potassium-sodium (GT267-004)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Secondary Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
See also
  Status Clinical Trial Phase
Completed NCT03181516 - Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics Phase 2
Recruiting NCT03895593 - Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Completed NCT04212403 - Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB) N/A
Terminated NCT02900196 - Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders N/A
Completed NCT01782755 - Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial Phase 2
Completed NCT06109740 - Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit N/A
Suspended NCT00591357 - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy Phase 4
Completed NCT00700557 - Probiotics at the Treatment of Antibiotic Associated Diarrhea Phase 4
Active, not recruiting NCT03256708 - Prevention of Antibiotic-Associated Diarrhoea With Prolardii N/A
Completed NCT04321460 - Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults. Phase 3
Completed NCT05607056 - Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults N/A
Recruiting NCT05845073 - The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms N/A
Completed NCT01143623 - Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults Phase 2/Phase 3
Completed NCT02127814 - Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile N/A
Completed NCT00641199 - Probiotics for Prevention of Antibiotic-associated Diarrhea N/A
Completed NCT02462590 - Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial Phase 4
Terminated NCT01143272 - Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea Phase 3
Completed NCT03755765 - Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics Early Phase 1
Completed NCT05990972 - Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea N/A
Completed NCT02746198 - Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) N/A