Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) (ASCEND I)

September 14, 2011 updated by: Warner Chilcott

A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

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
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
      • Golden, Colorado, United States
        • Research Facility
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Research Site
    • Florida
      • Ft Myers, Florida, United States
        • Research Site
      • Hollywood, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Facility
      • Decatur, Georgia, United States
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, United States
        • Research Site
      • Moline, Illinois, United States
        • Research Site
      • Rockford, Illinois, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Laurel, Maryland, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Research Site
      • Somerville, New Jersey, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
      • Pomona, New York, United States
        • Research Site
      • Poughkeepsie, New York, United States
        • Research Facility
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Facility
      • Nashville, Tennessee, United States
        • Research Facility
    • Texas
      • Ft Worth, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Site
      • Falls Church, Virginia, United States
        • Research Facility
      • Norfolk, Virginia, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed diagnosis of ulcerative colitis

Exclusion Criteria:

  • a history of allergy or hypersensitivity to salicylates or aminosalicylates;
  • a history of extensive small bowel resection

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
Active Comparator: 1
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Experimental: 2
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
Time Frame: 6 weeks
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
Time Frame: 3 weeks
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
3 weeks
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
Time Frame: Week 3
PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Week 3
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
Time Frame: Week 6
PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Week 6
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
Time Frame: Week 3
0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.
Week 3
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
Time Frame: Week 6
0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.
Week 6
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
Time Frame: Week 3
0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.
Week 3
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
Time Frame: Week 6
0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.
Week 6
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
Time Frame: Week 3
0-generally well, 1-fair, 2-poor, 3-terrible
Week 3
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
Time Frame: Week 6
0-generally well, 1-fair, 2-poor, 3-terrible
Week 6
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
Time Frame: Week 3
0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.
Week 3
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
Time Frame: Week 6
0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.
Week 6

Collaborators and Investigators

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

Sponsor

Warner Chilcott

Investigators

  • Study Director: Jeffery Kralstein, MD, Procter and Gamble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000083

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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