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

NCT ID: NCT00676832

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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 moderate to severe ulcerative colitis as assessed by flexible sigmoidoscopy, unless colonoscopy is clinically indicated, and rectal bleeding will be randomized to placebo or one of four doses of COLAL-PRED (equivalent to 40, 60, 80, or 120 mg of prednisolone). The effectiveness and safety of COLAL-PRED will be evaluated at baseline, and after 2 weeks and 4 weeks of treatment. Additional follow-up measurements will take place 7 days post cessation of treatment.

The systemic absorption of COLAL-PRED will be determined by measuring blood levels of prednisolone, prednisolone sodium metasulfobenzoate (PMSBS) and metasulfobenzoate at Week 4.

Hypothalamic-pituitary-adrenocortical (HPA) axis response will be monitored by measuring morning serum cortisol levels at Baseline, Week 2, Week 4, and at follow-up visit and cortisol levels following adrenocorticotrophic hormone (ACTH) stimulation testing at Baseline and Week 4.

Conditions

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Colitis, Ulcerative

Keywords

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colitis ulcerative moderate severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solid capsule dosage form administered orally once daily.

Group 2

Group Type EXPERIMENTAL

COLAL-PRED

Intervention Type 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.

Group 3

Group Type EXPERIMENTAL

COLAL-PRED

Intervention Type 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.

Group 4

Group Type EXPERIMENTAL

COLAL-PRED

Intervention Type 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.

Group 5

Group Type EXPERIMENTAL

COLAL-PRED

Intervention Type 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.

Interventions

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Placebo

Placebo solid capsule dosage form administered orally once daily.

Intervention Type DRUG

COLAL-PRED

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.

Intervention Type DRUG

Other Intervention Names

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prednisolone sodium metasulfobenzoate (PMSBS) prednisolone sodium metasulfobenzoate (PMSBS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prometheus Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Prometheus Laboratories, Inc.

Principal Investigators

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David T. Rubin, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Hospitals

Locations

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Prometheus Investigational Site #059

Birmingham, Alabama, United States

Site Status

Prometheus Investigational Site #042

Huntsville, Alabama, United States

Site Status

Prometheus Investigational Site #081

Huntsville, Alabama, United States

Site Status

Prometheus Investigational Site #033

Montgomery, Alabama, United States

Site Status

Prometheus Investigational Site #067

Scottsdale, Arizona, United States

Site Status

Prometheus Investigational Site #090

Tucson, Arizona, United States

Site Status

Prometheus Investigational Site #068

Jonesboro, Arkansas, United States

Site Status

Prometheus Investigational Site #065

Little Rock, Arkansas, United States

Site Status

Prometheus Investigational Site #093

Lowell, Arkansas, United States

Site Status

Prometheus Investigational Site 062

Fresno, California, United States

Site Status

Prometheus Investigational Site #057

Madera, California, United States

Site Status

Prometheus Investigational Site #060

Palm Springs, California, United States

Site Status

Prometheus Investigational Site #095

Roseville, California, United States

Site Status

Prometheus Investigational Site #003

San Carlos, California, United States

Site Status

Prometheus Investigational Site #022

San Diego, California, United States

Site Status

Prometheus Investigational Site #052

Santa Monica, California, United States

Site Status

Prometheus Investigational Site #086

West Covina, California, United States

Site Status

Prometheus Investigational Site #097

Lafayette, Colorado, United States

Site Status

Prometheus Investigational Site #006

Littleton, Colorado, United States

Site Status

Prometheus Investigational SIte #036

Thornton, Colorado, United States

Site Status

Prometheus Investigational Site #031

Hamden, Connecticut, United States

Site Status

Prometheus Investigational Site #083

Hartford, Connecticut, United States

Site Status

Prometheus Investigational Site #023

Cape Coral, Florida, United States

Site Status

Prometheus Investigational Site #075

Cape Coral, Florida, United States

Site Status

Prometheus Investigational Site #076

Hollywood, Florida, United States

Site Status

Prometheus Investigational Site #007

Jacksonville, Florida, United States

Site Status

Prometheus Investigational Site #008

Miami, Florida, United States

Site Status

Prometheus Investigational Site #027

Sarasota, Florida, United States

Site Status

Prometheus Investigational Site #066

Winter Park, Florida, United States

Site Status

Prometheus Investigational Site #005

Atlanta, Georgia, United States

Site Status

Prometheus Investigational Site #044

Atlanta, Georgia, United States

Site Status

Prometheus Investigational Site #010

Arlington Heights, Illinois, United States

Site Status

Prometheus Investigational Site 041

Chicago, Illinois, United States

Site Status

Prometheus Investigational Site # 001

Chicago, Illinois, United States

Site Status

Prometheus Investigational Site #089

Peoria, Illinois, United States

Site Status

Prometheus Investigational Site #059

Anderson, Indiana, United States

Site Status

Prometheus Investigational Site #015

Davenport, Iowa, United States

Site Status

Prometheus Investigational Site #051

Topeka, Kansas, United States

Site Status

Prometheus Investigational Site #039

Baton Rouge, Louisiana, United States

Site Status

Prometheus Investigational Site #061

Lafayette, Louisiana, United States

Site Status

Prometheus Investigational Site 092

New Orleans, Louisiana, United States

Site Status

Prometheus Investigational Site 100

Shreveport, Louisiana, United States

Site Status

Prometheus Investigational Site #016

Chevy Chase, Maryland, United States

Site Status

Prometheus Investigational Site #046

Hagerstown, Maryland, United States

Site Status

Prometheus Investigational Site #035

Laurel, Maryland, United States

Site Status

Prometheus Investigational Site #025

Lutherville, Maryland, United States

Site Status

Prometheus Investigational Site #037

Boston, Massachusetts, United States

Site Status

Prometheus Investigational Site #018

Braintree, Massachusetts, United States

Site Status

Prometheus Investigational Site #091

Southbridge, Massachusetts, United States

Site Status

Prometheus Investigational Site # 050

Chesterfield, Michigan, United States

Site Status

Prometheus Investigational Site #011

Novi, Michigan, United States

Site Status

Prometheus Investigational Site #072

Wyoming, Michigan, United States

Site Status

Prometheus Investigational Site #098

Plymouth, Minnesota, United States

Site Status

Prometheus Investigational Site #021

Jackson, Mississippi, United States

Site Status

Prometheus Investigational Site #019

Mexico, Missouri, United States

Site Status

Prometheus Investigational Site #017

Lebanon, New Hampshire, United States

Site Status

Prometheus Investigational Site #014

Cedar Knolls, New Jersey, United States

Site Status

Prometheus Investigational Site #009

Egg Harbor, New Jersey, United States

Site Status

Prometheus Investigational Site #063

Ocean City, New Jersey, United States

Site Status

Prometheus Investigational Site #080

Brooklyn, New York, United States

Site Status

Prometheus Investigational Site #002

Great Neck, New York, United States

Site Status

Prometheus Investigational Site #079

Rochester, New York, United States

Site Status

Prometheus Investigational Site 043

Rockville Centre, New York, United States

Site Status

Prometheus Investigational Site 087

Stony Brook, New York, United States

Site Status

Prometheus Investigational Site #013

Charlotte, North Carolina, United States

Site Status

Prometheus Investigational Site #047

Greenville, North Carolina, United States

Site Status

Prometheus Investigational Site #058

Wilmington, North Carolina, United States

Site Status

Prometheus Investigational Site #069

Columbus, Ohio, United States

Site Status

Prometheus Investigational Site #070

Dayton, Ohio, United States

Site Status

Prometheus Investigational Site #064

Dayton, Ohio, United States

Site Status

Prometheus Investigational Site #055

Mentor, Ohio, United States

Site Status

Prometheus Investigational Site #094

Westlake, Ohio, United States

Site Status

Prometheus Investigational Site #028

Tulsa, Oklahoma, United States

Site Status

Prometheus Investigational Site #049

Tulsa, Oklahoma, United States

Site Status

Prometheus Investigational Site #030

Philadelphia, Pennsylvania, United States

Site Status

Prometheus Investigational Site #038

Philadelphia, Pennsylvania, United States

Site Status

Prometheus Investigational Site #034

Sayre, Pennsylvania, United States

Site Status

Prometheus Investigational Site #045

Charleston, South Carolina, United States

Site Status

Prometheus Investigational Site #084

Franklin, Tennessee, United States

Site Status

Prometheus Investigational Site #020

Germantown, Tennessee, United States

Site Status

Prometheus Investigational Site #053

Nashville, Tennessee, United States

Site Status

Prometheus Investigational Site #074

Union City, Tennessee, United States

Site Status

Prometheus Investigational Site 101

Denton, Texas, United States

Site Status

Prometheus Investigational Site #071

Plano, Texas, United States

Site Status

Prometheus Investigational Site #026

San Antonio, Texas, United States

Site Status

Prometheus Investigational Site #073

San Antonio, Texas, United States

Site Status

Prometheus Investigational Site #082

Sugar Land, Texas, United States

Site Status

Prometheus Investigational Site #012

Ogden, Utah, United States

Site Status

Prometheus Investigational Site #040

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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08CP01

Identifier Type: -

Identifier Source: org_study_id