NCT01086553

Brief Summary

This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) 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
471

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

2.5 years

First QC Date

March 12, 2010

Last Update Submit

October 29, 2014

Conditions

Crohn´s Disease

Keywords

Crohn´s diseasebudesonideinduction of remission

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)

    8 weeks

Secondary Outcomes (2)

  • Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points

    8 weeks

  • Adverse events

    8 weeks

Study Arms (2)

A

EXPERIMENTAL

9mg budesonide OD

Drug: budesonide

B

ACTIVE COMPARATOR

3mg budesonide TID

Drug: budesonide

Interventions

budesonideDRUG

9mg budesonide OD

A

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent,
  • Age 18 to 75 years,
  • Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria \[endoscopy not older than 12 months or if older, then clinical signs (e.g., pain localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes\],
  • Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,
  • Active phase of disease (200 \< CDAI \< 400),
  • Negative pregnancy test in females of childbearing potential,
  • Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

You may not qualify if:

  • Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms,
  • Septic complications,
  • Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
  • 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 (e.g., major stenosis, serious bleeding, peritonitis, ileus),
  • Clinical signs of stricturing disease,
  • Subileus within the last 6 months (subileus with inflammatory hint allowed),
  • Suspicion of ileus, subileus or corresponding symptoms,
  • Parenteral or tube feeding,
  • Active peptic ulcer disease, local intestinal infection, or known established cataract,
  • Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured,
  • Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\]), liver cirrhosis, or portal hypertension,
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken

Frankfurt, 60431, Germany

Location

Related Publications (1)

  • Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsova E, Altorjay I, Tuculanu D, Bunganic I, Pokrotnieks J, Kupcinskas L, Dilger K, Greinwald R, Mueller R; International Budenofalk Study Group. Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2014 Sep;8(9):970-80. doi: 10.1016/j.crohns.2014.01.021. Epub 2014 Feb 15.

    PMID: 24534142RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Axel Dignass, Prof.

    Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken

    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 12, 2010

First Posted

March 15, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

DE(1)