Randomized Placebo Controlled Trial of Budesonide-MMX™ 6 mg and 9 mg in Patients With Ulcerative Colitis

Tracking Information

Start Date  ICMJEJune 2008
Estimated Primary Completion DateJuly 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00679380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 15, 2008)
Efficacy & safety of oral budesonide-MMX 6 mg and 9 mg compared to 3 times daily Asacol®. To evaluate the improvement in rectal bleeding,endoscopic, histological, bio humoral parameters. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJERandomized Placebo Controlled Trial of Budesonide-MMX™ 6 mg and 9 mg in Patients With Ulcerative Colitis
Official Title  ICMJEEfficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC
Brief Summary

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEUlcerative Colitis
Intervention  ICMJE
  • Procedure: Blood sampling, endoscopy
    Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
  • Drug: Budesonide-MMX
    Budesonide-MMX 6 mg or 9 mg
  • Drug: Entocort
    Entocort® capsules
  • Drug: Placebo
Study Arms / Comparison Groups
  • 1: Experimental
    Budesonide-MMX™ tablets (6 mg)
    • Procedure: Blood sampling, endoscopy
    • Drug: Budesonide-MMX
  • 2: Experimental
    Budesonide-MMX™ tablets (9 mg)
    • Procedure: Blood sampling, endoscopy
    • Drug: Budesonide-MMX
  • 3: Active Comparator
    Entocort® capsules
    • Procedure: Blood sampling, endoscopy
    • Drug: Entocort
  • 4: Placebo Comparator
    • Procedure: Blood sampling, endoscopy
    • Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE492
Estimated Completion DateAugust 2009
Estimated Primary Completion DateJuly 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients fulfilling the following criteria at the screening visit are eligible for participation in the study:

    • Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months.
    • Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.
    • All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate <1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period.
    • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects.
    • Ability to co-operate with the investigator and to comply with the requirements of the entire study.
    • Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.

Exclusion Criteria:

  • Patients who meet any of the following criteria at screening visit are to be excluded from study participation:

    • Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).
    • Patients with severe ulcerative colitis (UCDAI >10).
    • Patients with infectious colitis.
    • Evidence or history of toxic megacolon.
    • Severe anaemia, leucopaenia or granulocytopaenia.
    • Use of oral or rectal steroids in the last 4 weeks.
    • Use of immuno-suppressive agents in the last 8 weeks before the study.
    • Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3 months.
    • Concomitant use of any rectal preparation.
    • Concomitant use of antibiotics.
    • Concurrent use of CYP3A4 inducers or CYP3A4 inhibitors. See Section 4.2, Table 5 for complete list.
    • Patients with verified, presumed or expected pregnancy or ongoing lactation.
    • Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x upper limit of normal for ALT, AST, GGT or creatinine).
    • Patient with severe diseases in other organs and systems.
    • Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.
    • Patients diagnosed with type 1 diabetes.
    • Patients diagnosed with, or with a family history of, glaucoma.
    • All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.
    • Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded).
    • Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs).
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Desirée Richold+44 (0) 1256 460090desiree.richold@iconplc.com
Location Countries  ICMJEAustralia,   Belgium,   Estonia,   France,   Italy,   Latvia,   Lithuania,   Poland,   Romania,   Russian Federation,   Slovakia,   Sweden,   Ukraine,   United Kingdom

Administrative Information

Responsible PartyDesirée Richold/ Clinical Project Manager, ICON Clinical Research
Study ID Numbers  ICMJECB-01-02/02
Study Sponsor  ICMJECosmo Technologies Ltd
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Simon TravisJohn Radcliffe Hospital
Information Provided ByCosmo Technologies Ltd
Verification DateJanuary 2009