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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT00676832

Run by

Prometheus Laboratories

People needed

190

Starts

2008-05-01

Expected to finish

2009-10-01

Last updated by the study team

2010-09-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Prometheus Investigational Site #042 — Huntsville, Alabama, United States
• Prometheus Investigational Site #081 — Huntsville, Alabama, United States
• Prometheus Investigational Site #033 — Montgomery, Alabama, United States
• Prometheus Investigational Site #067 — Scottsdale, Arizona, United States
• Prometheus Investigational Site #090 — Tucson, Arizona, United States
• Prometheus Investigational Site #068 — Jonesboro, Arkansas, United States
• Prometheus Investigational Site #065 — Little Rock, Arkansas, United States
• Prometheus Investigational Site #093 — Lowell, Arkansas, United States
• Prometheus Investigational Site 062 — Fresno, California, United States
• Prometheus Investigational Site #057 — Madera, California, United States
• Prometheus Investigational Site #060 — Palm Springs, California, United States
• Prometheus Investigational Site #095 — Roseville, California, United States
• Prometheus Investigational Site #003 — San Carlos, California, United States
• Prometheus Investigational Site #022 — San Diego, California, United States
• Prometheus Investigational Site #052 — Santa Monica, California, United States
• Prometheus Investigational Site #086 — West Covina, California, United States
• Prometheus Investigational Site #097 — Lafayette, Colorado, United States
• Prometheus Investigational Site #006 — Littleton, Colorado, United States
• Prometheus Investigational SIte #036 — Thornton, Colorado, United States
• Prometheus Investigational Site #031 — Hamden, Connecticut, United States
• Prometheus Investigational Site #083 — Hartford, Connecticut, United States
• Prometheus Investigational Site #023 — Cape Coral, Florida, United States
• Prometheus Investigational Site #075 — Cape Coral, Florida, United States
• Prometheus Investigational Site #076 — Hollywood, Florida, United States
• Prometheus Investigational Site #059 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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