9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

October 29, 2014 updated by: Dr. Falk Pharma GmbH

Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frankfurt, Germany, 60431
        • Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • Abnormal renal function (Cystatin C > ULN),
  • Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
  • History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma),
  • Treatment with immunosuppressants or anti-cancer drugs, e.g., 6 TG, methotrexate, tacrolimus, cyclophosphamide, 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,
  • Treatment with ketoconazole or other CYP3A inhibitors within the last month before baseline visit,
  • Treatment with anti-TNF-alpha therapy within 3 months before baseline visit,
  • Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
  • > 6 mg/d budesonide po within 2 weeks before baseline visit,
  • Steroids for inhalation within 2 weeks before baseline visit,
  • Patients known to be steroid-refractory,
  • Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
  • Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except ≤ 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed),
  • Known intolerance/hypersensitivity to study drug,
  • Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
9mg budesonide OD
9mg budesonide OD
3mg budesonide TID
Active Comparator: B
3mg budesonide TID
9mg budesonide OD
3mg budesonide TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points
Time Frame: 8 weeks
8 weeks
Adverse events
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Axel Dignass, Prof., Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 30, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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