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Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease (TRUST-2)
This study has been completed.
Sponsor:
Dr. Falk Pharma GmbH
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01279577
First received: January 18, 2011
Last updated: February 9, 2015
Last verified: February 2015
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Purpose
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.
This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
| Condition | Intervention | Phase |
|---|---|---|
| Crohn´s Disease | Drug: Low dose TSO Drug: Medium dose TSO Drug: High dose TSO Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Dr. Falk Pharma GmbH:
Primary Outcome Measures:
- Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ]
- Adverse events [ Time Frame: 12 weeks ]
| Enrollment: | 254 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low dose TSO
Low dose suspension of TSO
|
Drug: Low dose TSO
Low dose TSO suspension
|
|
Experimental: Medium dose TSO
Medium dose suspension of TSO
|
Drug: Medium dose TSO
Medium dose TSO suspension
|
|
Experimental: High dose TSO
High dose suspension of TSO
|
Drug: High dose TSO
High dose TSO suspension
|
|
Placebo Comparator: Placebo
Placebo solution
|
Drug: Placebo
Placebo solution
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Major Inclusion Criteria:
- Signed informed consent,
- Man or woman between 18 and 75 years of age,
- Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria,
- Negative pregnancy test in females of childbearing potential.
Major Exclusion Criteria:
- Bowel surgery within the last 3 months prior to baseline,
- Resection of more than 50 cm of the ileum,
- Ileostomy or colostomy,
- Septic complications,
- Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),
- Abscess, perforation, fistulas, or perianal lesions,
- Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
- Clinical signs of stricturing disease,
- Parenteral or tube feeding,
- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN] at screening), liver cirrhosis, or portal hypertension,
- Abnormal renal function (Cystatin C > ULN) at screening,
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results,
- Any condition associated with significant immunosuppression,
- Active malignancy or treatment with anticancer drugs during the last 5 years.
- Existing or intended pregnancy or breast-feeding,
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279577
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279577
Locations
| Germany | |
| Klinikum der Johann Wolfgang Goethe-Universität | |
| Frankfurt a.M., Hessen, Germany, 60590 | |
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
| Principal Investigator: | Jürgen Schölmerich, Prof. | Klinikum der Johann Wolfgang Goethe-Universität |
More Information
| Responsible Party: | Dr. Falk Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01279577 History of Changes |
| Other Study ID Numbers: |
TSU-2/CDA 2006-000720-13 ( EudraCT Number ) |
| Study First Received: | January 18, 2011 |
| Last Updated: | February 9, 2015 |
Keywords provided by Dr. Falk Pharma GmbH:
|
Crohn´s disease Trichuris suis randomized |
placebo induction of remission porcine whipworm |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 27, 2017