Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prometheus Laboratories
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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:

1. Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met:

1. Must be on a stable dose 2 weeks prior to baseline

2. Must maintain the stable dose until treatment end.

2. Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met:

1. On therapy continually for at least 3 months prior to baseline.

2. And on a stable dose for at least 2 weeks prior to baseline.

3. And must maintain the stable dose until the end of study drug treatment.

Exclusion Criteria:

• 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