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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01279577
First received: January 18, 2011
Last updated: November 14, 2013
Last verified: November 2013

January 18, 2011
November 14, 2013
November 2010
February 2014   (final data collection date for primary outcome measure)
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279577 on ClinicalTrials.gov Archive Site
  • Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn´s Disease
  • Drug: Low dose TSO
    Low dose TSO suspension
  • Drug: Medium dose TSO
    Medium dose TSO suspension
  • Drug: High dose TSO
    High dose TSO suspension
  • Drug: Placebo
    Placebo solution
  • Experimental: Low dose TSO
    Low dose suspension of TSO
    Intervention: Drug: Low dose TSO
  • Experimental: Medium dose TSO
    Medium dose suspension of TSO
    Intervention: Drug: Medium dose TSO
  • Experimental: High dose TSO
    High dose suspension of TSO
    Intervention: Drug: High dose TSO
  • Placebo Comparator: Placebo
    Placebo solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
August 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01279577
TSU-2/CDA, 2006-000720-13
Yes
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Jürgen Schölmerich, Prof. Klinikum der Johann Wolfgang Goethe-Universität
Dr. Falk Pharma GmbH
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP