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Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease (TRUST-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01279577
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Crohn´s Disease Drug: Low dose TSO Drug: Medium dose TSO Drug: High dose TSO Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : November 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ]
  2. Adverse events [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279577


Locations
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Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt a.M., Hessen, Germany, 60590
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
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Principal Investigator: Jürgen Schölmerich, Prof. Klinikum der Johann Wolfgang Goethe-Universität
More Information
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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01279577    
Other Study ID Numbers: TSU-2/CDA
2006-000720-13 ( EudraCT Number )
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Dr. Falk Pharma GmbH:
Crohn´s disease
Trichuris suis
randomized
 placebo
induction of remission
porcine whipworm
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases