Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
ASCEND I
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
1 other identifier
interventional
301
1 country
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2001
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 20, 2007
CompletedResults Posted
Study results publicly available
June 22, 2011
CompletedSeptember 16, 2011
September 1, 2011
2 years
December 19, 2007
May 24, 2011
September 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (11)
Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
3 weeks
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
Week 3
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
Week 6
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
Week 3
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
Week 6
- +6 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORmesalamine 2.4 g/day (400 mg tablet) for 6 weeks
2
EXPERIMENTALmesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- confirmed diagnosis of ulcerative colitis
You may not qualify if:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (44)
Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Sacramento, California, United States
Research Site
San Francisco, California, United States
Research Site
Denver, Colorado, United States
Research Facility
Golden, Colorado, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Fort Myers, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Miami, Florida, United States
Research Facility
Atlanta, Georgia, United States
Research Facility
Decatur, Georgia, United States
Research Site
Arlington Heights, Illinois, United States
Research Site
Moline, Illinois, United States
Research Site
Rockford, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Metairie, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Laurel, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
New Brunswick, New Jersey, United States
Research Site
Somerville, New Jersey, United States
Research Site
Great Neck, New York, United States
Research Site
Pomona, New York, United States
Research Facility
Poughkeepsie, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Facility
Memphis, Tennessee, United States
Research Facility
Nashville, Tennessee, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Charlottesville, Virginia, United States
Research Facility
Falls Church, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Related Publications (2)
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.
PMID: 21385195DERIVEDLichtenstein 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.
PMID: 21255059DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Jeffery Kralstein, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 20, 2007
Study Start
February 1, 2001
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
September 16, 2011
Results First Posted
June 22, 2011
Record last verified: 2011-09