NCT01279577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

January 18, 2011

Last Update Submit

February 9, 2015

Conditions

Crohn´s Disease

Keywords

Crohn´s diseaseTrichuris suisrandomizedplaceboinduction of remissionporcine whipworm

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150

    12 weeks

Secondary Outcomes (2)

  • Reduction of > 100 points in CDAI

    12 weeks

  • Adverse events

    12 weeks

Study Arms (4)

Low dose TSO

EXPERIMENTAL

Low dose suspension of TSO

Drug: Low dose TSO

Medium dose TSO

EXPERIMENTAL

Medium dose suspension of TSO

Drug: Medium dose TSO

High dose TSO

EXPERIMENTAL

High dose suspension of TSO

Drug: High dose TSO

Placebo

PLACEBO COMPARATOR

Placebo solution

Drug: Placebo

Interventions

Low dose TSODRUG

Low dose TSO suspension

Low dose TSO
Medium dose TSODRUG

Medium dose TSO suspension

Medium dose TSO
High dose TSODRUG

High dose TSO suspension

High dose TSO
PlaceboDRUG

Placebo solution

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt a.M., Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jürgen Schölmerich, Prof.

    Klinikum der Johann Wolfgang Goethe-Universität

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

DE(1)