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| Sponsor: | Coronado Biosciences, Inc. |
|---|---|
| Information provided by (Responsible Party): | Coronado Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01434693 |
Purpose
This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Biological: Trichuris suis ova |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease |
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TSO 500 |
Biological: Trichuris suis ova
single dose
|
| Experimental: TSO 2500 |
Biological: Trichuris suis ova
single dose
|
| Experimental: TSO 7500 |
Biological: Trichuris suis ova
single dose
|
| Placebo Comparator: Placebo |
Biological: Trichuris suis ova
single dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| Borland-Groover Clinic | |
| Jacksonville, Florida, United States, 32256 | |
| Shafran Gastroenterology Center | |
| Winter Park, Florida, United States, 32789 | |
| United States, Michigan | |
| Clinical Research Institute of Michigan, LLC | |
| Chesterfield, Michigan, United States, 48047 | |
| United States, Missouri | |
| Midwest Center for Clinical Research | |
| Lee's Summit, Missouri, United States, 64064 | |
| Center for Digestive & Liver Diseases, Inc | |
| Mexico, Missouri, United States, 65265 | |
| United States, New York | |
| Long Island Clinical Research Associates, LLP | |
| Great Neck, New York, United States, 11021 | |
More Information
| Responsible Party: | Coronado Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01434693 History of Changes |
| Other Study ID Numbers: | CNDO 201-002 |
| Study First Received: | September 13, 2011 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
T. suis ova Crohn's disease |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |