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View Clinical Trial (Medical Research Study)
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(CB-01-02/01)Randomized Placebo Controlled Trial of Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg in Patients With Ulcerative Colitis - NCT00679432-92262 (Clinical Trial 221454)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy221454.aspx
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| City: |
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Palm Springs |
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State:
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CA |
| Zip Code: |
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92262 |
| Conditions: |
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Ulcerative Colitis |
| Purpose: |
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The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg
tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to
determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.
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| Study summary: |
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Each patient will receive one of the following regimens in the morning after breakfast:
1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or
2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or
3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or
4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily
for 8 weeks.
Each patient will also receive on each day after the midday meal and after the evening meal
either:
- two Asacol® 400 mg over-encapsulated tablets (Group 4), or
- the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3)
Hence, each patient is to take seven tablets per day of active or placebo study medication
as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo
over-encapsulated tablets of Asacol® will be used to maintain the study blind using a
double-dummy technique.
During the study, five visits to the clinical center are scheduled: one at Screening and
three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety
follow up visit will take place about 2 weeks after the final study visit. If a patient is
withdrawn from the study before Day 56, they will be asked to attend the study center as
soon as possible thereafter so that the Final visit assessments can be conducted. |
| Criteria: |
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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 anemia, leucopenia or granulocytopenia.
- 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 tumor 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 intolerance to salicylates.
- 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-humoral 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). |
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| Study is available at: |
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Santarus Clinical Investigational Site 5070
Palm Springs, CA 92262
United States
Primary Contact:
Theres Gautille
Email: tgautille@santarus.com
Phone: (858) 314-5758 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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