Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
1 other identifier
interventional
386
3 countries
57
Brief Summary
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
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 Sep 2000
Typical duration for phase_3
57 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
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 13, 2003
CompletedFirst Posted
Study publicly available on registry
November 17, 2003
CompletedResults Posted
Study results publicly available
July 28, 2011
CompletedJune 29, 2015
June 1, 2015
3 years
November 13, 2003
March 25, 2011
June 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment \[stool frequency, rectal bleeding, PFA, sigmoidoscopy\] and no worsening in any other clinical assessments)
6 Weeks
Secondary Outcomes (11)
Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
6 weeks
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
6 Weeks
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
6 Weeks
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
6 Weeks
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
6 Weeks
- +6 more secondary outcomes
Study Arms (2)
Asacol 2.4 g/day
ACTIVE COMPARATORAsacol (2.4 g/day)
Asacol 4.8 g/day
EXPERIMENTALAsacol (4.8 g/day)
Interventions
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Eligibility Criteria
You may qualify if:
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
You may not qualify if:
- Patients will be excluded from admission to the study if they have/are:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (\>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
- received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- received any other topical rectal therapy during the week prior to the Screening Visit;
- received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- if female, positive pregnancy test, or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (57)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
AGMG Clinical Research
Anaheim, California, 92801, United States
Research Site
Los Angeles, California, 90067, United States
Community Clinical Trials
Orange, California, 38305, United States
AGMG Clinical Research
Orange, California, 92869, United States
Research Site
Sacramento, California, 95825, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
Research Site
Arvada, Colorado, 80002, United States
Research Site
Englewood, Colorado, 80110, United States
Center for Medical Research, LLC
Manchester, Connecticut, 06040, United States
Center for GI Disorders
Hollywood, Florida, 33021, United States
Research Site
Maitland, Florida, 32789, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Research Site
Zephyrhills, Florida, 33540, United States
Southeast Research Associates
Marietta, Georgia, 30067, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
GI Research
Metairie, Louisiana, 70001, United States
Louisiana Research Center
Shreveport, Louisiana, 71103, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Research Site
Baltimore, Maryland, 21215, United States
Digestive Disease Associates
Baltimore, Maryland, 21229, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
PharmaTrials, Inc.
Hillsborough, New Jersey, 08844, United States
Research Site
Forest Hills, New York, 11375, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Research Site
New York, New York, 10128, United States
Carolinas Digestive Health Associates
Charlotte, North Carolina, 28262, United States
Research Site
Raleigh, North Carolina, 27612, United States
Research Site
Statesville, North Carolina, 28677, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Research Site
Cincinnati, Ohio, 45267, United States
Research Site
Columbus, Ohio, 43215, United States
GI & Liver Consultants
Dayton, Ohio, 45440, United States
Research Site
Oklahoma City, Oklahoma, 73190, United States
Research Site
Tulsa, Oklahoma, 74135, United States
West Hills Gastroenterology Group
Portland, Oregon, 97225, United States
Research Site
Altoona, Pennsylvania, 16602, United States
Research Site
Hanover, Pennsylvania, 17331, United States
Regional Research Institute
Jackson, Tennessee, 38305, United States
Research Site
Austin, Texas, 78705, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Houston, Texas, 77030, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Research Site
Temple, Texas, 76508, United States
Research Site
Ogden, Utah, 84405, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22902, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Fredericksburg, Virginia, 22401, United States
Richmond GI Research
Richmond, Virginia, 23226, United States
Research Site
Spokane, Washington, 99207, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207, United States
Research Site
Richmond, British Columbia, V7C 5L9, Canada
Research Site
Toronto, Ontario, M5B 1W8, Canada
University of Puerto Rico, School of Medicine
San Juan, 00935, Puerto Rico
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
Piotr Krzeski, 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
November 13, 2003
First Posted
November 17, 2003
Study Start
September 1, 2000
Primary Completion
September 1, 2003
Study Completion
September 1, 2003
Last Updated
June 29, 2015
Results First Posted
July 28, 2011
Record last verified: 2015-06