Overview

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