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Colitis, UlcerativePhase 2NCT00676832

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

A Phase 2 study testing COLAL-PRED in people with Colitis, Ulcerative, run by Prometheus Laboratories at 89 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
COLAL-PRED
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
190 participants
Where
89 sitesUnited States
Study dates
May 2008to Oct 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

89 sites in 1 country.

89 sites in 1 country

United States89 sites

  • Prometheus Investigational Site #059

    Anderson, Indiana, 46016

  • Prometheus Investigational Site #010

    Arlington Heights, Illinois, 60005

  • Prometheus Investigational Site #005

    Atlanta, Georgia, 30342

  • Prometheus Investigational Site #044

    Atlanta, Georgia, 30342

  • Prometheus Investigational Site #039

    Baton Rouge, Louisiana, 70809

  • Prometheus Investigational Site #059

    Birmingham, Alabama, 35233

  • Prometheus Investigational Site #037

    Boston, Massachusetts, 02115

  • Prometheus Investigational Site #018

    Braintree, Massachusetts, 02184

  • Prometheus Investigational Site #080

    Brooklyn, New York, 14642

  • Prometheus Investigational Site #023

    Cape Coral, Florida, 33904

  • Prometheus Investigational Site #075

    Cape Coral, Florida, 33904

  • Prometheus Investigational Site #014

    Cedar Knolls, New Jersey, 07927

  • Prometheus Investigational Site #045

    Charleston, South Carolina, 29414

  • Prometheus Investigational Site #013

    Charlotte, North Carolina, 28207

  • Prometheus Investigational Site # 050

    Chesterfield, Michigan, 48047

  • Prometheus Investigational Site #016

    Chevy Chase, Maryland, 20815

  • Prometheus Investigational Site 041

    Chicago, Illinois, 60612

  • Prometheus Investigational Site # 001

    Chicago, Illinois, 60637

  • Prometheus Investigational Site #069

    Columbus, Ohio, 43215

  • Prometheus Investigational Site #015

    Davenport, Iowa, 52807

  • Prometheus Investigational Site #070

    Dayton, Ohio, 45415

  • Prometheus Investigational Site #064

    Dayton, Ohio, 45440

  • Prometheus Investigational Site 101

    Denton, Texas, 76201

  • Prometheus Investigational Site #009

    Egg Harbor, New Jersey, 08234

  • Prometheus Investigational Site #084

    Franklin, Tennessee, 37067

  • Prometheus Investigational Site 062

    Fresno, California, 93721

  • Prometheus Investigational Site #020

    Germantown, Tennessee, 38138

  • Prometheus Investigational Site #002

    Great Neck, New York, 11021

  • Prometheus Investigational Site #047

    Greenville, North Carolina, 27834

  • Prometheus Investigational Site #046

    Hagerstown, Maryland, 21742

  • Prometheus Investigational Site #031

    Hamden, Connecticut, 06518

  • Prometheus Investigational Site #083

    Hartford, Connecticut, 06106

  • Prometheus Investigational Site #076

    Hollywood, Florida, 33021

  • Prometheus Investigational Site #042

    Huntsville, Alabama, 35801

  • Prometheus Investigational Site #081

    Huntsville, Alabama, 35801

  • Prometheus Investigational Site #021

    Jackson, Mississippi, 39202

  • Prometheus Investigational Site #007

    Jacksonville, Florida, 32256

  • Prometheus Investigational Site #068

    Jonesboro, Arkansas, 72401

  • Prometheus Investigational Site #097

    Lafayette, Colorado, 80026

  • Prometheus Investigational Site #061

    Lafayette, Louisiana, 70503

  • Prometheus Investigational Site #035

    Laurel, Maryland, 20707

  • Prometheus Investigational Site #017

    Lebanon, New Hampshire, 03756

  • Prometheus Investigational Site #065

    Little Rock, Arkansas, 72205

  • Prometheus Investigational Site #006

    Littleton, Colorado, 80120

  • Prometheus Investigational Site #093

    Lowell, Arkansas, 72745

  • Prometheus Investigational Site #025

    Lutherville, Maryland, 21093

  • Prometheus Investigational Site #057

    Madera, California, 93637

  • Prometheus Investigational Site #055

    Mentor, Ohio, 44060

  • Prometheus Investigational Site #019

    Mexico, Missouri, 65265

  • Prometheus Investigational Site #008

    Miami, Florida, 33144

  • Prometheus Investigational Site #033

    Montgomery, Alabama, 36116

  • Prometheus Investigational Site #053

    Nashville, Tennessee, 37205

  • Prometheus Investigational Site 092

    New Orleans, Louisiana, 70005

  • Prometheus Investigational Site #011

    Novi, Michigan, 48377

  • Prometheus Investigational Site #063

    Ocean City, New Jersey, 07712

  • Prometheus Investigational Site #012

    Ogden, Utah, 84405

  • Prometheus Investigational Site #060

    Palm Springs, California, 92262

  • Prometheus Investigational Site #089

    Peoria, Illinois, 61602

  • Prometheus Investigational Site #030

    Philadelphia, Pennsylvania, 19106

  • Prometheus Investigational Site #038

    Philadelphia, Pennsylvania, 19107

  • Prometheus Investigational Site #071

    Plano, Texas, 75075

  • Prometheus Investigational Site #098

    Plymouth, Minnesota, 55446

  • Prometheus Investigational Site #079

    Rochester, New York, 14642

  • Prometheus Investigational Site 043

    Rockville Centre, New York, 11570

  • Prometheus Investigational Site #095

    Roseville, California, 95661

  • Prometheus Investigational Site #026

    San Antonio, Texas, 78229

  • Prometheus Investigational Site #073

    San Antonio, Texas, 78229

  • Prometheus Investigational Site #003

    San Carlos, California, 94070

  • Prometheus Investigational Site #022

    San Diego, California, 92117

  • Prometheus Investigational Site #052

    Santa Monica, California, 90404

  • Prometheus Investigational Site #027

    Sarasota, Florida, 34239

  • Prometheus Investigational Site #034

    Sayre, Pennsylvania, 18840

  • Prometheus Investigational Site #067

    Scottsdale, Arizona, 85260

  • Prometheus Investigational Site #040

    Seattle, Washington, 98195

  • Prometheus Investigational Site 100

    Shreveport, Louisiana, 71103

  • Prometheus Investigational Site #091

    Southbridge, Massachusetts, 01550

  • Prometheus Investigational Site 087

    Stony Brook, New York, 11794

  • Prometheus Investigational Site #082

    Sugar Land, Texas, 77479

  • Prometheus Investigational SIte #036

    Thornton, Colorado, 80229

  • Prometheus Investigational Site #051

    Topeka, Kansas, 66606

  • Prometheus Investigational Site #090

    Tucson, Arizona, 85710

  • Prometheus Investigational Site #028

    Tulsa, Oklahoma, 74104

  • Prometheus Investigational Site #049

    Tulsa, Oklahoma, 74135

  • Prometheus Investigational Site #074

    Union City, Tennessee, 38261

  • Prometheus Investigational Site #086

    West Covina, California, 91790

  • Prometheus Investigational Site #094

    Westlake, Ohio, 44145

  • Prometheus Investigational Site #058

    Wilmington, North Carolina, 28403

  • Prometheus Investigational Site #066

    Winter Park, Florida, 32708

  • Prometheus Investigational Site #072

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Placebo, COLAL-PRED
Keywords
colitis, ulcerative, moderate, severe
Medical subject headings
Colitis, Ulcerative, Colitis, Ulcer, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called prednisolone sodium metasulfobenzoate (PMSBS)

    Placebo solid capsule dosage form administered orally once daily.

  • COLAL-PREDDrug

    Also called prednisolone sodium metasulfobenzoate (PMSBS)

    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.

Study groups in NCT00676832
Study groupRoleWhat they receive
Group 1Placebo comparatorNot described
Receives: Drug: Placebo
Group 2ExperimentalNot described
Receives: Drug: COLAL-PRED
Group 3ExperimentalNot described
Receives: Drug: COLAL-PRED
Group 4ExperimentalNot described
Receives: Drug: COLAL-PRED
Group 5ExperimentalNot described
Receives: Drug: COLAL-PRED

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 4 of the study or at time of withdrawal

Secondary outcomes (1)

  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.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676832
Sponsor's protocol ID
08CP01
Status last verified
Sep 2010
First submitted
9 May 2008
Last updated
29 Sep 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COLAL-PRED in people with Colitis, Ulcerative, run by Prometheus Laboratories at 89 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00676832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2010.

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