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

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00577473
• Collaborator: (none)
• Enrollment: 301
• Locations: 44
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: mesalamine; Drug: mesalamine	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 301 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2001
• Actual Primary Completion Date: Feb 1, 2003
• Actual Study Completion Date: Feb 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 mesalamine 2.4 g/day (400 mg tablet) for 6 weeks	Drug: mesalamine; mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Experimental: 2 mesalamine 4.8 g/day (800 mg tablet) for 6 weeks	Drug: mesalamine; mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Classified as Treatment Success at Week 6, ITT Population [6 weeks]

   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

1. Percentage of Patients Classified as Treatment Success at Week 3, ITT Population [3 weeks]

   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.

2. Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients [Week 3]

   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.

3. Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients [Week 6]

   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.

4. Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) [Week 3]

   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.

5. Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) [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, Scoring Scale: 0-good thru 3-worse.

6. Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) [Week 3]

   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.

7. Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) [Week 6]

   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.

8. Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) [Week 3]

   0-generally well, 1-fair, 2-poor, 3-terrible

9. Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) [Week 6]

   0-generally well, 1-fair, 2-poor, 3-terrible

10. Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) [Week 3]

    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.

11. Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) [Week 6]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Anaheim	California	United States
3	Research Site	Sacramento	California	United States
4	Research Site	San Francisco	California	United States
5	Research Site	Denver	Colorado	United States
6	Research Facility	Golden	Colorado	United States
7	Research Site	Bridgeport	Connecticut	United States
8	Research Site	Ft Myers	Florida	United States
9	Research Site	Hollywood	Florida	United States
10	Research Site	Jupiter	Florida	United States
11	Research Site	Miami	Florida	United States
12	Research Facility	Atlanta	Georgia	United States
13	Research Facility	Decatur	Georgia	United States
14	Research Site	Arlington Heights	Illinois	United States
15	Research Site	Moline	Illinois	United States
16	Research Site	Rockford	Illinois	United States
17	Research Site	Wichita	Kansas	United States
18	Research Site	Metairie	Louisiana	United States
19	Research Site	Baltimore	Maryland	United States
20	Research Site	Laurel	Maryland	United States
21	Research Site	Detroit	Michigan	United States
22	Research Site	New Brunswick	New Jersey	United States
23	Research Site	Somerville	New Jersey	United States
24	Research Site	Great Neck	New York	United States
25	Research Site	Pomona	New York	United States
26	Research Facility	Poughkeepsie	New York	United States
27	Research Site	Raleigh	North Carolina	United States
28	Research Site	Winston-Salem	North Carolina	United States
29	Research Site	Cincinnati	Ohio	United States
30	Research Site	Tulsa	Oklahoma	United States
31	Research Site	Philadelphia	Pennsylvania	United States
32	Research Site	Pittsburgh	Pennsylvania	United States
33	Research Site	Charleston	South Carolina	United States
34	Research Facility	Memphis	Tennessee	United States
35	Research Facility	Nashville	Tennessee	United States
36	Research Site	Ft Worth	Texas	United States
37	Research Site	Houston	Texas	United States
38	Research Site	San Antonio	Texas	United States
39	Research Site	Burlington	Vermont	United States
40	Research Site	Charlottesville	Virginia	United States
41	Research Facility	Falls Church	Virginia	United States
42	Research Site	Norfolk	Virginia	United States
43	Research Site	Tacoma	Washington	United States
44	Research Site	Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• Warner Chilcott

Investigators

• Study Director: Jeffery Kralstein, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00577473
• Other Study ID Numbers: 2000083
• First Posted: Dec 20, 2007
• Last Update Posted: Sep 16, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Mesalamine

Study Results

Participant Flow

Recruitment Details	Screening began 9 Feb 2001

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Period Title: Overall Study
STARTED	154	147
ITT Population	150	136
COMPLETED	133	123
NOT COMPLETED	21	24

Baseline Characteristics

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day	Total
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks	Total of all reporting groups
Overall Participants	154	147	301
Age, Customized (Number) [Number]
18 - 64 years	141 91.6%	133 90.5%	274 91%
>= 65 years	13 8.4%	14 9.5%	27 9%
Sex: Female, Male (Count of Participants)
Female	79 51.3%	67 45.6%	146 48.5%
Male	75 48.7%	80 54.4%	155 51.5%
Race/Ethnicity, Customized (Partcipants) [Number]
Caucasian	122	116	238
Black or African American	18	18	36
Asian (Indian)	2	2	4
Asian (Oriental)	1	0	1
Hispanic	10	9	19
Multi-racial/other	1	2	3

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	150	136
Number [Percentage of Participants]	51.3 33.3%	55.9 38%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4411
	Comments	4.8 g/day compared to 2.4 g/day
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0455
	Confidence Interval	(2-Sided) 95%; -7.01 to 16.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	150	137
Number [Percentage of Participants]	42.0 27.3%	38.7 26.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5677
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.0331
	Confidence Interval	(2-Sided) 95%; -14.67 to 8.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	49.3 32%	44.8 30.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4730
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.0445
	Confidence Interval	(2-Sided) 95%; -16.6 to 7.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	61.4 39.9%	64.8 44.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5761
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0339
	Confidence Interval	(2-Sided) 95%; -8.48 to 15.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	46.7 30.3%	54.3 36.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2150
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0766
	Confidence Interval	(2-Sided) 95%; -4.41 to 19.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	63.2 41%	66.7 45.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5569
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0351
	Confidence Interval	(2-Sided) 95%; -8.18 to 15.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	48.1 31.2%	59.1 40.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0769
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.1091
	Confidence Interval	(2-Sided) 95%; -1.10 to 22.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	60.2 39.1%	71.5 48.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0551
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.1139
	Confidence Interval	(2-Sided) 95%; -0.13 to 22.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	42.2 27.4%	49.6 33.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2306
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0738
	Confidence Interval	(2-Sided) 95%; -4.66 to 19.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	54.1 35.1%	60.7 41.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2931
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0652
	Confidence Interval	(2-Sided) 95%; -5.60 to 18.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	51.5 33.4%	52.0 35.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9349
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0051
	Confidence Interval	(2-Sided) 95%; -11.67 to 12.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All Randomized Patients

Arm/Group Title	Asacol 2.4 g/Day	Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks	2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Measure Participants	154	147
Number [Percentage of Participants]	66.7 43.3%	73.2 49.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Asacol 2.4 g/Day, Asacol 4.8 g/Day
	Comments	It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2583
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0650
	Confidence Interval	(2-Sided) 95%; -4.72 to 17.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 week treatment period
Adverse Event Reporting Description	Screening started February 2001, study completed November 2002
Arm/Group Title	Asacol 2.4 g/Day		Asacol 4.8 g/Day
Arm/Group Description	2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks		2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
All Cause Mortality
	Asacol 2.4 g/Day		Asacol 4.8 g/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Asacol 2.4 g/Day		Asacol 4.8 g/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/154 (1.9%)		1/147 (0.7%)
Gastrointestinal disorders
Worsening of Ulcerative Colitis	1/154 (0.6%)	1	0/147 (0%)	0
Rectal Bleeding	1/154 (0.6%)	1	0/147 (0%)	0
Diarrhea	1/154 (0.6%)	1	0/147 (0%)	0
Cholecystitis	1/154 (0.6%)	1	0/147 (0%)	0
Nervous system disorders
Pain, Right Upper Quadrant	1/154 (0.6%)	1	0/147 (0%)	0
Epigastric Pain	0/154 (0%)	0	1/147 (0.7%)	1
Reproductive system and breast disorders
Uterine Fibroids Exacerbation	1/154 (0.6%)	1	0/147 (0%)	0
Ovarian Cyst Exacerbation	1/154 (0.6%)	1	0/147 (0%)	0
Vascular disorders
Abdominal Pain, Left Side	1/154 (0.6%)	1	0/147 (0%)	0
Other (Not Including Serious) Adverse Events
	Asacol 2.4 g/Day		Asacol 4.8 g/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	56/154 (36.4%)		48/147 (32.7%)
Gastrointestinal disorders
Nausea	2/154 (1.3%)		9/147 (6.1%)
Abdominal Pain	7/154 (4.5%)		4/147 (2.7%)
Diarrhea	5/154 (3.2%)		4/147 (2.7%)
Flatulence	3/154 (1.9%)		6/147 (4.1%)
Colitis Ulcer	6/154 (3.9%)		2/147 (1.4%)
Vomiting	1/154 (0.6%)		6/147 (4.1%)
Dyspepsia	2/154 (1.3%)		3/147 (2%)
Infections and infestations
Infection	5/154 (3.2%)		5/147 (3.4%)
Flu Syndrome	5/154 (3.2%)		0/147 (0%)
Nervous system disorders
Headache	9/154 (5.8%)		8/147 (5.4%)
Dizziness	4/154 (2.6%)		1/147 (0.7%)
Respiratory, thoracic and mediastinal disorders
Cough	4/154 (2.6%)		1/147 (0.7%)
Skin and subcutaneous tissue disorders
Rash	3/154 (1.9%)		3/147 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.