Randomized Placebo Controlled Trial of Budesonide-MMX™ 6 mg and 9 mg in Patients With Ulcerative Colitis
Information source: Cosmo Technologies Ltd
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Blood sampling, endoscopy (Procedure); Budesonide-MMX (Drug); Entocort (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Cosmo Technologies Ltd Official(s) and/or principal investigator(s):
Simon Travis, Principal Investigator, Affiliation: John Radcliffe Hospital
Overall contact:
Desirée Richold, Phone: +44 (0) 2380 688555, Email: RicholdD@iconuk.com
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.
Clinical Details
Official title: Efficacy 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Desirée Richold, Phone: +44 (0) 2380 688555, Email: RicholdD@iconuk.com
St Marks Hospital, Harrow HA1 3UJ, United Kingdom; Recruiting
Naila Arebi, Phone: 020 8235 4285
Naila Arebi, Principal Investigator
John Radcliffe Hospital, Headington, Oxford OX3 9DU, United Kingdom; Active, not recruiting
Additional Information
Starting date: June 2008
Ending date: August 2009
Last updated: October 8, 2008
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