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

NCT00676832 | Completed Phase 2

• 1 other identifier: 08CP01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 89

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.

Conditions

Colitis, Ulcerative

Keywords

colitis; ulcerative; moderate; severe

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with Complete Response at Week 4 defined as a decrease from baseline in the DAI score by ≥ 30% or ≥ 3 points, and with a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding sub-score of 0 or 1.

  Week 4 of the study or at time of withdrawal

Secondary Outcomes (1)

• The proportion of patients in Clinical Remission defined as a DAI score of ≤ 2 points, with no-individual DAI sub-score > 1 at Week 4. Patients in remission by this definition will have a rectal bleeding DAI sub-score of either 0 or 1.

  Week 4

Study Arms (5)

Group 1

PLACEBO COMPARATOR

Drug: Placebo

Group 2

EXPERIMENTAL

Drug: COLAL-PRED

Group 3

EXPERIMENTAL

Drug: COLAL-PRED

Group 4

EXPERIMENTAL

Drug: COLAL-PRED

Group 5

EXPERIMENTAL

Drug: COLAL-PRED

Interventions

Placebo DRUG

Placebo solid capsule dosage form administered orally once daily.

Also known as: prednisolone sodium metasulfobenzoate (PMSBS)

Group 1

COLAL-PRED DRUG

The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.

Also known as: prednisolone sodium metasulfobenzoate (PMSBS)

Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Prometheus Laboratories: lead

Study Sites (89)

Prometheus Investigational Site #059

Birmingham, Alabama, 35233, United States

Location

Prometheus Investigational Site #042

Huntsville, Alabama, 35801, United States

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Prometheus Investigational Site #081

Huntsville, Alabama, 35801, United States

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Prometheus Investigational Site #033

Montgomery, Alabama, 36116, United States

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Prometheus Investigational Site #067

Scottsdale, Arizona, 85260, United States

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Prometheus Investigational Site #090

Tucson, Arizona, 85710, United States

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Prometheus Investigational Site #068

Jonesboro, Arkansas, 72401, United States

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Prometheus Investigational Site #065

Little Rock, Arkansas, 72205, United States

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Prometheus Investigational Site #093

Lowell, Arkansas, 72745, United States

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Prometheus Investigational Site 062

Fresno, California, 93721, United States

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Prometheus Investigational Site #057

Madera, California, 93637, United States

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Prometheus Investigational Site #060

Palm Springs, California, 92262, United States

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Prometheus Investigational Site #095

Roseville, California, 95661, United States

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Prometheus Investigational Site #003

San Carlos, California, 94070, United States

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Prometheus Investigational Site #022

San Diego, California, 92117, United States

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Prometheus Investigational Site #052

Santa Monica, California, 90404, United States

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Prometheus Investigational Site #086

West Covina, California, 91790, United States

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Prometheus Investigational Site #097

Lafayette, Colorado, 80026, United States

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Prometheus Investigational Site #006

Littleton, Colorado, 80120, United States

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Prometheus Investigational SIte #036

Thornton, Colorado, 80229, United States

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Prometheus Investigational Site #031

Hamden, Connecticut, 06518, United States

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Prometheus Investigational Site #083

Hartford, Connecticut, 06106, United States

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Prometheus Investigational Site #023

Cape Coral, Florida, 33904, United States

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Prometheus Investigational Site #075

Cape Coral, Florida, 33904, United States

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Prometheus Investigational Site #076

Hollywood, Florida, 33021, United States

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Prometheus Investigational Site #007

Jacksonville, Florida, 32256, United States

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Prometheus Investigational Site #008

Miami, Florida, 33144, United States

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Prometheus Investigational Site #027

Sarasota, Florida, 34239, United States

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Prometheus Investigational Site #066

Winter Park, Florida, 32708, United States

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Prometheus Investigational Site #005

Atlanta, Georgia, 30342, United States

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Prometheus Investigational Site #044

Atlanta, Georgia, 30342, United States

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Prometheus Investigational Site #010

Arlington Heights, Illinois, 60005, United States

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Prometheus Investigational Site 041

Chicago, Illinois, 60612, United States

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Prometheus Investigational Site # 001

Chicago, Illinois, 60637, United States

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Prometheus Investigational Site #089

Peoria, Illinois, 61602, United States

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Prometheus Investigational Site #059

Anderson, Indiana, 46016, United States

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Prometheus Investigational Site #015

Davenport, Iowa, 52807, United States

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Prometheus Investigational Site #051

Topeka, Kansas, 66606, United States

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Prometheus Investigational Site #039

Baton Rouge, Louisiana, 70809, United States

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Prometheus Investigational Site #061

Lafayette, Louisiana, 70503, United States

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Prometheus Investigational Site 092

New Orleans, Louisiana, 70005, United States

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Prometheus Investigational Site 100

Shreveport, Louisiana, 71103, United States

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Prometheus Investigational Site #016

Chevy Chase, Maryland, 20815, United States

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Prometheus Investigational Site #046

Hagerstown, Maryland, 21742, United States

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Prometheus Investigational Site #035

Laurel, Maryland, 20707, United States

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Prometheus Investigational Site #025

Lutherville, Maryland, 21093, United States

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Prometheus Investigational Site #037

Boston, Massachusetts, 02115, United States

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Prometheus Investigational Site #018

Braintree, Massachusetts, 02184, United States

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Prometheus Investigational Site #091

Southbridge, Massachusetts, 01550, United States

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Prometheus Investigational Site # 050

Chesterfield, Michigan, 48047, United States

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Prometheus Investigational Site #011

Novi, Michigan, 48377, United States

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Prometheus Investigational Site #072

Wyoming, Michigan, 49519, United States

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Prometheus Investigational Site #098

Plymouth, Minnesota, 55446, United States

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Prometheus Investigational Site #021

Jackson, Mississippi, 39202, United States

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Prometheus Investigational Site #019

Mexico, Missouri, 65265, United States

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Prometheus Investigational Site #017

Lebanon, New Hampshire, 03756, United States

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Prometheus Investigational Site #014

Cedar Knolls, New Jersey, 07927, United States

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Prometheus Investigational Site #009

Egg Harbor, New Jersey, 08234, United States

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Prometheus Investigational Site #063

Ocean City, New Jersey, 07712, United States

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Prometheus Investigational Site #080

Brooklyn, New York, 14642, United States

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Prometheus Investigational Site #002

Great Neck, New York, 11021, United States

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Prometheus Investigational Site #079

Rochester, New York, 14642, United States

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Prometheus Investigational Site 043

Rockville Centre, New York, 11570, United States

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Prometheus Investigational Site 087

Stony Brook, New York, 11794, United States

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Prometheus Investigational Site #013

Charlotte, North Carolina, 28207, United States

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Prometheus Investigational Site #047

Greenville, North Carolina, 27834, United States

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Prometheus Investigational Site #058

Wilmington, North Carolina, 28403, United States

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Prometheus Investigational Site #069

Columbus, Ohio, 43215, United States

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Prometheus Investigational Site #070

Dayton, Ohio, 45415, United States

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Prometheus Investigational Site #064

Dayton, Ohio, 45440, United States

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Prometheus Investigational Site #055

Mentor, Ohio, 44060, United States

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Prometheus Investigational Site #094

Westlake, Ohio, 44145, United States

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Prometheus Investigational Site #028

Tulsa, Oklahoma, 74104, United States

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Prometheus Investigational Site #049

Tulsa, Oklahoma, 74135, United States

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Prometheus Investigational Site #030

Philadelphia, Pennsylvania, 19106, United States

Location

Prometheus Investigational Site #038

Philadelphia, Pennsylvania, 19107, United States

Location

Prometheus Investigational Site #034

Sayre, Pennsylvania, 18840, United States

Location

Prometheus Investigational Site #045

Charleston, South Carolina, 29414, United States

Location

Prometheus Investigational Site #084

Franklin, Tennessee, 37067, United States

Location

Prometheus Investigational Site #020

Germantown, Tennessee, 38138, United States

Location

Prometheus Investigational Site #053

Nashville, Tennessee, 37205, United States

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Prometheus Investigational Site #074

Union City, Tennessee, 38261, United States

Location

Prometheus Investigational Site 101

Denton, Texas, 76201, United States

Location

Prometheus Investigational Site #071

Plano, Texas, 75075, United States

Location

Prometheus Investigational Site #026

San Antonio, Texas, 78229, United States

Location

Prometheus Investigational Site #073

San Antonio, Texas, 78229, United States

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Prometheus Investigational Site #082

Sugar Land, Texas, 77479, United States

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Prometheus Investigational Site #012

Ogden, Utah, 84405, United States

Location

Prometheus Investigational Site #040

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Ulcer; Lymphoma, Follicular

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David T. Rubin, M.D.

  The University of Chicago Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

US (89)