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

September 27, 2010 updated by: Prometheus Laboratories

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Prometheus Investigational Site #059
      • Huntsville, Alabama, United States, 35801
        • Prometheus Investigational Site #042
      • Huntsville, Alabama, United States, 35801
        • Prometheus Investigational Site #081
      • Montgomery, Alabama, United States, 36116
        • Prometheus Investigational Site #033
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Prometheus Investigational Site #067
      • Tucson, Arizona, United States, 85710
        • Prometheus Investigational Site #090
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Prometheus Investigational Site #068
      • Little Rock, Arkansas, United States, 72205
        • Prometheus Investigational Site #065
      • Lowell, Arkansas, United States, 72745
        • Prometheus Investigational Site #093
    • California
      • Fresno, California, United States, 93721
        • Prometheus Investigational Site 062
      • Madera, California, United States, 93637
        • Prometheus Investigational Site #057
      • Palm Springs, California, United States, 92262
        • Prometheus Investigational Site #060
      • Roseville, California, United States, 95661
        • Prometheus Investigational Site #095
      • San Carlos, California, United States, 94070
        • Prometheus Investigational Site #003
      • San Diego, California, United States, 92117
        • Prometheus Investigational Site #022
      • Santa Monica, California, United States, 90404
        • Prometheus Investigational Site #052
      • West Covina, California, United States, 91790
        • Prometheus Investigational Site #086
    • Colorado
      • Lafayette, Colorado, United States, 80026
        • Prometheus Investigational Site #097
      • Littleton, Colorado, United States, 80120
        • Prometheus Investigational Site #006
      • Thornton, Colorado, United States, 80229
        • Prometheus Investigational SIte #036
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Prometheus Investigational Site #031
      • Hartford, Connecticut, United States, 06106
        • Prometheus Investigational Site #083
    • Florida
      • Cape Coral, Florida, United States, 33904
        • Prometheus Investigational Site #023
      • Cape Coral, Florida, United States, 33904
        • Prometheus Investigational Site #075
      • Hollywood, Florida, United States, 33021
        • Prometheus Investigational Site #076
      • Jacksonville, Florida, United States, 32256
        • Prometheus Investigational Site #007
      • Miami, Florida, United States, 33144
        • Prometheus Investigational Site #008
      • Sarasota, Florida, United States, 34239
        • Prometheus Investigational Site #027
      • Winter Park, Florida, United States, 32708
        • Prometheus Investigational Site #066
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Prometheus Investigational Site #005
      • Atlanta, Georgia, United States, 30342
        • Prometheus Investigational Site #044
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Prometheus Investigational Site #010
      • Chicago, Illinois, United States, 60612
        • Prometheus Investigational Site 041
      • Chicago, Illinois, United States, 60637
        • Prometheus Investigational Site # 001
      • Peoria, Illinois, United States, 61602
        • Prometheus Investigational Site #089
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Prometheus Investigational Site #059
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Prometheus Investigational Site #015
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Prometheus Investigational Site #051
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Prometheus Investigational Site #039
      • Lafayette, Louisiana, United States, 70503
        • Prometheus Investigational Site #061
      • New Orleans, Louisiana, United States, 70005
        • Prometheus Investigational Site 092
      • Shreveport, Louisiana, United States, 71103
        • Prometheus Investigational Site 100
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Prometheus Investigational Site #016
      • Hagerstown, Maryland, United States, 21742
        • Prometheus Investigational Site #046
      • Laurel, Maryland, United States, 20707
        • Prometheus Investigational Site #035
      • Lutherville, Maryland, United States, 21093
        • Prometheus Investigational Site #025
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Prometheus Investigational Site #037
      • Braintree, Massachusetts, United States, 02184
        • Prometheus Investigational Site #018
      • Southbridge, Massachusetts, United States, 01550
        • Prometheus Investigational Site #091
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Prometheus Investigational Site # 050
      • Novi, Michigan, United States, 48377
        • Prometheus Investigational Site #011
      • Wyoming, Michigan, United States, 49519
        • Prometheus Investigational Site #072
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Prometheus Investigational Site #098
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Prometheus Investigational Site #021
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Prometheus Investigational Site #019
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Prometheus Investigational Site #017
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Prometheus Investigational Site #014
      • Egg Harbor Township, New Jersey, United States, 08234
        • Prometheus Investigational Site #009
      • Ocean, New Jersey, United States, 07712
        • Prometheus Investigational Site #063
    • New York
      • Brooklyn, New York, United States, 14642
        • Prometheus Investigational Site #080
      • Great Neck, New York, United States, 11021
        • Prometheus Investigational Site #002
      • Rochester, New York, United States, 14642
        • Prometheus Investigational Site #079
      • Rockville Center, New York, United States, 11570
        • Prometheus Investigational Site 043
      • Stony Brook, New York, United States, 11794
        • Prometheus Investigational Site 087
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Prometheus Investigational Site #013
      • Greenville, North Carolina, United States, 27834
        • Prometheus Investigational Site #047
      • Wilmington, North Carolina, United States, 28403
        • Prometheus Investigational Site #058
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Prometheus Investigational Site #069
      • Dayton, Ohio, United States, 45415
        • Prometheus Investigational Site #070
      • Dayton, Ohio, United States, 45440
        • Prometheus Investigational Site #064
      • Mentor, Ohio, United States, 44060
        • Prometheus Investigational Site #055
      • Westlake, Ohio, United States, 44145
        • Prometheus Investigational Site #094
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Prometheus Investigational Site #028
      • Tulsa, Oklahoma, United States, 74135
        • Prometheus Investigational Site #049
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Prometheus Investigational Site #030
      • Philadelphia, Pennsylvania, United States, 19107
        • Prometheus Investigational Site #038
      • Sayre, Pennsylvania, United States, 18840
        • Prometheus Investigational Site #034
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Prometheus Investigational Site #045
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Prometheus Investigational Site #084
      • Germantown, Tennessee, United States, 38138
        • Prometheus Investigational Site #020
      • Nashville, Tennessee, United States, 37205
        • Prometheus Investigational Site #053
      • Union City, Tennessee, United States, 38261
        • Prometheus Investigational Site #074
    • Texas
      • Denton, Texas, United States, 76201
        • Prometheus Investigational Site 101
      • Plano, Texas, United States, 75075
        • Prometheus Investigational Site #071
      • San Antonio, Texas, United States, 78229
        • Prometheus Investigational Site #026
      • San Antonio, Texas, United States, 78229
        • Prometheus Investigational Site #073
      • Sugar Land, Texas, United States, 77479
        • Prometheus Investigational Site #082
    • Utah
      • Ogden, Utah, United States, 84405
        • Prometheus Investigational Site #012
    • Washington
      • Seattle, Washington, United States, 98195
        • Prometheus Investigational Site #040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
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.
Other Names:
  • prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 3
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.
Other Names:
  • prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 4
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.
Other Names:
  • prednisolone sodium metasulfobenzoate (PMSBS)
Experimental: Group 5
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.
Other Names:
  • prednisolone sodium metasulfobenzoate (PMSBS)
Placebo Comparator: Group 1
Drug: Placebo
Placebo solid capsule dosage form administered orally once daily.
Other Names:
  • prednisolone sodium metasulfobenzoate (PMSBS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Week 4 of the study or at time of withdrawal
Week 4 of the study or at time of withdrawal

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prometheus Laboratories

Investigators

  • Principal Investigator: David T. Rubin, M.D., The University of Chicago Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 27, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08CP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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