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

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577473
• Other study ID #: 2000083
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: September 14, 2011
• Start date: February 2001
• Est. completion date: February 2003

Study information

• Verified date: September 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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:
• mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
• mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	3 weeks	Yes
Secondary	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.	Week 3	No
Secondary	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.	Week 6	No
Secondary	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.	Week 3	No
Secondary	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.	Week 6	No
Secondary	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.	Week 3	No
Secondary	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.	Week 6	No
Secondary	Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)	0-generally well, 1-fair, 2-poor, 3-terrible	Week 3	No
Secondary	Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)	0-generally well, 1-fair, 2-poor, 3-terrible	Week 6	No
Secondary	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.	Week 3	No
Secondary	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.	Week 6	No