Status:
COMPLETED
Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Prometheus Laboratories
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-design, dose-ranging study. Eligible patients with a DAI score of 6 to 10 (inclusive), plus endoscopic evidence of modera...
Eligibility Criteria
Inclusion
- Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods such as contraceptive pill, or two forms of barrier contraception.
- Disease Activity Index (DAI) Score of 6-10 (inclusive) at the Baseline Visit.
- Previous colonoscopic and biopsy diagnosis of ulcerative colitis with negative evaluation of the ileum within 3 years of the screening visit.
- Endoscopic evidence of moderate or severe mucosal disease as assessed by flexible sigmoidoscopy, with a minimum confirmed diagnosis of moderate ulcerative colitis.
- The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met:
- Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met:
- Must be on a stable dose 2 weeks prior to baseline
- Must maintain the stable dose until treatment end.
- Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met:
- On therapy continually for at least 3 months prior to baseline.
- And on a stable dose for at least 2 weeks prior to baseline.
- And must maintain the stable dose until the end of study drug treatment.
Exclusion
- History of colonic or rectal surgery, excluding hemorrhoidal surgery or an appendectomy.
- Pregnant or breast-feeding females.
- Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, adrenocortical insufficiency, or any other unstable medical condition.
- Known hypersensitivity to corticosteroids
- Use of oral 5-aminosalicylic acid (5-ASA) or oral corticosteroids during the immediate screening period.
- Use of immunosuppressive drugs or antibiotics at any time within four weeks prior to screening.
- Diagnosis of Crohn's disease; indeterminate colitis; microscopic colitis; ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis; or gonococcal proctitis; Clostridium difficile colitis.
- History of tuberculosis or HIV
- Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis
- History of alcohol or drug abuse
- Known malignancy or history of malignancy that would reduce life expectancy
- Recent immunization with live viral vaccines
- History of or active peptic ulcer disease or gastritis
- Generalized infections such as systemic fungal or hepatitis B or C
- History of steroid induced severe hypertension, steroid-induced psychosis, or any other severe steroid-related adverse reaction
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00676832
Start Date
May 1 2008
End Date
October 1 2009
Last Update
September 29 2010
Active Locations (89)
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1
Prometheus Investigational Site #059
Birmingham, Alabama, United States, 35233
2
Prometheus Investigational Site #042
Huntsville, Alabama, United States, 35801
3
Prometheus Investigational Site #081
Huntsville, Alabama, United States, 35801
4
Prometheus Investigational Site #033
Montgomery, Alabama, United States, 36116