search
Back to results

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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
mesalamine
mesalamine
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Facility
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Facility
  • Research Facility
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Facility
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Facility
  • Research Facility
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Facility
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

mesalamine 2.4 g/day (400 mg tablet) for 6 weeks

mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Outcomes

Primary Outcome Measures

Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
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.

Secondary Outcome Measures

Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
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.
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
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.
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
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.
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
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.
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
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.
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
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.
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
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.
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
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.
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
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.

Full Information

First Posted
December 19, 2007
Last Updated
September 14, 2011
Sponsor
Warner Chilcott
search

1. Study Identification

Unique Protocol Identification Number
NCT00577473
Brief Title
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Acronym
ASCEND I
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Intervention Type
Drug
Intervention Name(s)
mesalamine
Intervention Description
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Intervention Type
Drug
Intervention Name(s)
mesalamine
Intervention Description
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Primary Outcome Measure Information:
Title
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
Description
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.
Time Frame
3 weeks
Title
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
Description
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.
Time Frame
Week 3
Title
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
Description
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.
Time Frame
Week 6
Title
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 3
Title
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 6
Title
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 3
Title
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 6
Title
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
Description
0-generally well, 1-fair, 2-poor, 3-terrible
Time Frame
Week 3
Title
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
Description
0-generally well, 1-fair, 2-poor, 3-terrible
Time Frame
Week 6
Title
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 3
Title
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
Description
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.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Kralstein, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Facility
City
Golden
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Ft Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Facility
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Facility
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Arlington Heights
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Moline
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Rockford
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Laurel
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Somerville
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Site
City
Pomona
State/Province
New York
Country
United States
Facility Name
Research Facility
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Facility
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Facility
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Ft Worth
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Facility
City
Falls Church
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21385195
Citation
Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.
Results Reference
derived
PubMed Identifier
21255059
Citation
Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs