NCT00300118

Brief Summary

The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

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

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

3.7 years

First QC Date

March 7, 2006

Last Update Submit

May 16, 2014

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of remission

Secondary Outcomes (5)

  • Response to treatment

  • Time to response

  • Time to remission

  • PGA

  • QoL

Study Arms (2)

A

EXPERIMENTAL
Drug: budesonide

B

ACTIVE COMPARATOR
Drug: mesalazine

Interventions

budesonideDRUG

9 mg

A
mesalazineDRUG

4.5 g

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria \[endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes\]
  • Localisation of CD either in terminal ileum, ascending colon or ileocolitis
  • Active phase of disease (200 \< CDAI \< 400)

You may not qualify if:

  • Known Crohn's lesion in the upper GI-tract (up to and including the jejunum) with present symptoms
  • CD in the rectum currently present
  • Short bowel syndrome
  • Septic complications
  • Baseline stool positive for germs causing bowel disease
  • Abscess, perforation or active fistulas
  • Ileostomy or colostomy
  • Resection of more than 50 cm of the ileum
  • Bowel surgery within the last 3 months
  • Immediate surgery required
  • Clinical signs of stricturing disease
  • Subileus within the last 6 months
  • Suspicion of ileus, subileus or corresponding symptomatology
  • Contra-indications, special warnings and precautions mentioned in SmPC
  • Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ev. Krankenhaus Hattingen GmbH

Hattingen, 45525, Germany

Location

Related Publications (1)

  • Tromm A, Bunganic I, Tomsova E, Tulassay Z, Lukas M, Kykal J, Batovsky M, Fixa B, Gabalec L, Safadi R, Kramm HJ, Altorjay I, Lohr H, Koutroubakis I, Bar-Meir S, Stimac D, Schaffeler E, Glasmacher C, Dilger K, Mohrbacher R, Greinwald R; International Budenofalk Study Group. Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. Gastroenterology. 2011 Feb;140(2):425-434.e1; quiz e13-4. doi: 10.1053/j.gastro.2010.11.004. Epub 2010 Nov 9.

    PMID: 21070781RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

BudesonideMesalamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compoundsmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Andreas Tromm, Professor

    Ev. Krankenhaus Hattingen GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

March 7, 2006

First Posted

March 8, 2006

Study Start

September 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

DE(1)