Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073021
• Other study ID #: 2000082
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2003
• Last updated: June 1, 2015
• Start date: September 2000
• Est. completion date: September 2003

Study information

• Verified date: June 2015
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Asacol 800 mg (mesalamine)
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
• Asacol 400 mg (mesalamine)
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily

Locations

Country	Name	City	State
Canada	Research Site	Richmond	British Columbia
Canada	Research Site	Toronto	Ontario
Puerto Rico	University of Puerto Rico, School of Medicine	San Juan
United States	Research Site	Altoona	Pennsylvania
United States	AGMG Clinical Research	Anaheim	California
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Research Site	Arvada	Colorado
United States	Research Site	Austin	Texas
United States	Digestive Disease Associates	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Carolinas Digestive Health Associates	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Metropolitan Gastroenterology Group	Chevy Chase	Maryland
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	GI & Liver Consultants	Dayton	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Research Site	Englewood	Colorado
United States	Research Site	Fairfax	Virginia
United States	Research Site	Forest Hills	New York
United States	Research Site	Fredricksburg	Virginia
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Research Site	Hanover	Pennsylvania
United States	PharmaTrials, Inc.	Hillsborough	New Jersey
United States	Center for GI Disorders	Hollywood	Florida
United States	Houston Medical Research Associates	Houston	Texas
United States	Research Site	Houston	Texas
United States	Regional Research Institute	Jackson	Tennessee
United States	Research Site	Los Angeles	California
United States	Research Site	Maitland	Florida
United States	Center for Medical Research, LLC	Manchester	Connecticut
United States	Southeast Research Associates	Marietta	Georgia
United States	GI Research	Metairie	Louisiana
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	AGMG Clinical Research	Orange	California
United States	Community Clinical Trials	Orange	California
United States	Advanced Gastroenterology Associates	Palm Harbor	Florida
United States	West Hills Gastroenterology Group	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Richmond GI Research	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Research Site	Sacramento	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Louisiana Research Center	Shreveport	Louisiana
United States	Research Site	Spokane	Washington
United States	Research Site	Statesville	North Carolina
United States	Research Site	Temple	Texas
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population	UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [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 and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]	6 weeks	No
Secondary	Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population	Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 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)	6 Weeks	No
Secondary	Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population	Sigmoidoscopy Assessment Score (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)	6 Weeks	No
Secondary	Percentage of Patients With an Improvement in Stool Frequency, ITT Population, 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	6 Weeks	No
Secondary	Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6	Rectal Bleeding (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)	6 Weeks	No
Secondary	Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6	PFA - 0=generally well, 1=fair, 2=poor, 3=terrible	6 Weeks	No
Secondary	Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6	PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.	6 Weeks	No
Secondary	Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients	IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.	3 Weeks	No
Secondary	Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients	IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.	6 Weeks	No
Secondary	Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients	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	No
Secondary	Percentage of Treatment Success Patients at Week 3, ITT 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)	3 Weeks	No