Trial Outcomes & Findings for Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) (NCT NCT00577473)
NCT ID: NCT00577473
Last Updated: 2011-09-16
Results Overview
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.
COMPLETED
PHASE3
301 participants
6 weeks
2011-09-16
Participant Flow
Screening began 9 Feb 2001
Participant milestones
| Measure |
Asacol 2.4 g/Day
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
147
|
|
Overall Study
ITT Population
|
150
|
136
|
|
Overall Study
COMPLETED
|
133
|
123
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
Reasons for withdrawal
| Measure |
Asacol 2.4 g/Day
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
8
|
7
|
Baseline Characteristics
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Baseline characteristics by cohort
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 - 64 years
|
141 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
122 Partcipants
n=5 Participants
|
116 Partcipants
n=7 Participants
|
238 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Partcipants
n=5 Participants
|
18 Partcipants
n=7 Participants
|
36 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Indian)
|
2 Partcipants
n=5 Participants
|
2 Partcipants
n=7 Participants
|
4 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Oriental)
|
1 Partcipants
n=5 Participants
|
0 Partcipants
n=7 Participants
|
1 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Partcipants
n=5 Participants
|
9 Partcipants
n=7 Participants
|
19 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial/other
|
1 Partcipants
n=5 Participants
|
2 Partcipants
n=7 Participants
|
3 Partcipants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=150 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=136 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
|
51.3 Percentage of Participants
|
55.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: 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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=150 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=137 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
|
42.0 Percentage of Participants
|
38.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 3Population: 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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
|
49.3 Percentage of Participants
|
44.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
|
61.4 Percentage of Participants
|
64.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 3Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
|
46.7 Percentage of Participants
|
54.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
|
63.2 Percentage of Participants
|
66.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 3Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
|
48.1 Percentage of Participants
|
59.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
|
60.2 Percentage of Participants
|
71.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 3Population: All Randomized Patients
0-generally well, 1-fair, 2-poor, 3-terrible
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
|
42.2 Percentage of Participants
|
49.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: All Randomized Patients
0-generally well, 1-fair, 2-poor, 3-terrible
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
|
54.1 Percentage of Participants
|
60.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 3Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
|
51.5 Percentage of Participants
|
52.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 6Population: All Randomized Patients
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.
Outcome measures
| Measure |
Asacol 2.4 g/Day
n=154 Participants
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 Participants
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
|
66.7 Percentage of Participants
|
73.2 Percentage of Participants
|
Adverse Events
Asacol 2.4 g/Day
Asacol 4.8 g/Day
Serious adverse events
| Measure |
Asacol 2.4 g/Day
n=154 participants at risk
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 participants at risk
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine Fibroids Exacerbation
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Reproductive system and breast disorders
Ovarian Cyst Exacerbation
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Worsening of Ulcerative Colitis
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Diarrhea
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Vascular disorders
Abdominal Pain, Left Side
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Cholecystitis
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Nervous system disorders
Pain, Right Upper Quadrant
|
0.65%
1/154 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Nervous system disorders
Epigastric Pain
|
0.00%
0/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.68%
1/147 • Number of events 1 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
Other adverse events
| Measure |
Asacol 2.4 g/Day
n=154 participants at risk
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
|
Asacol 4.8 g/Day
n=147 participants at risk
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.8%
9/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
5.4%
8/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
6.1%
9/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
7/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
2.7%
4/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Infections and infestations
Infection
|
3.2%
5/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
3.4%
5/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
5/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
2.7%
4/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
3/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
4.1%
6/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Colitis Ulcer
|
3.9%
6/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
1.4%
2/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
4.1%
6/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
3/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
2.0%
3/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
4/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.68%
1/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Nervous system disorders
Dizziness
|
2.6%
4/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.68%
1/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
2.0%
3/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
|
Infections and infestations
Flu Syndrome
|
3.2%
5/154 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
0.00%
0/147 • 6 week treatment period
Screening started February 2001, study completed November 2002
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60