Trial Outcomes & Findings for Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis (NCT NCT00713310)

Last Updated: 2012-04-05

Results Overview

PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small \<50% stool/10, small with most stools/20, large \>50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, \>8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score\<10 at Wk 6 (complete) or reduction of \>=20 points baseline to Wk 6 with Wk 6 score\>=10 (partial)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

83 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2012-04-05

Participant Flow

Recruitment began 16 Dec 2008

Participant milestones

Participant milestones
Measure	Low-Dose 17-\<33kg: AM - 2 Asacol 400mg \& 1 placebo, PM - 1 Asacol 400mg \& 1 placebo; 33-\<54kg: AM - 3 Asacol 400mg \& 2 placebo, PM - 2 Asacol 400mg \& 2 placebo; 54-\<90kg: AM \& PM - 3 Asacol 400mg \& 3 placebo	High-Dose 17-\<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-\<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-\<90kg: AM \& PM 6 Asacol 400mg
Overall Study STARTED	41	42
Overall Study mITT Population	41	41
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Low-Dose 17-\<33kg: AM - 2 Asacol 400mg \& 1 placebo, PM - 1 Asacol 400mg \& 1 placebo; 33-\<54kg: AM - 3 Asacol 400mg \& 2 placebo, PM - 2 Asacol 400mg \& 2 placebo; 54-\<90kg: AM \& PM - 3 Asacol 400mg \& 3 placebo	High-Dose 17-\<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-\<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-\<90kg: AM \& PM 6 Asacol 400mg
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-Dose n=41 Participants 17-\<33kg: AM - 2 Asacol 400mg \& 1 placebo, PM - 1 Asacol 400mg \& 1 placebo; 33-\<54kg: AM - 3 Asacol 400mg \& 2 placebo, PM - 2 Asacol 400mg \& 2 placebo; 54-\<90kg: AM \& PM - 3 Asacol 400mg \& 3 placebo	High-Dose n=42 Participants 17-\<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-\<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-\<90kg: AM \& PM 6 Asacol 400mg	Total n=83 Participants Total of all reporting groups
Age Continuous	13.0 years STANDARD_DEVIATION 3.2 • n=5 Participants	12.8 years STANDARD_DEVIATION 3.0 • n=7 Participants	12.9 years STANDARD_DEVIATION 3.1 • n=5 Participants
Age, Customized 5-8 years	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Age, Customized 9-17 years	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	23 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Canada	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Poland	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Croatia	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: miTT includes subjects who were randomized and took at least one dose of study medication

Outcome measures

Outcome measures
Measure	Low Dose n=41 Participants Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)	High Dose n=41 Participants High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population	56.1 % participants with treatment success	55.0 % participants with treatment success

SECONDARY outcome

Timeframe: Baseline and Week 6

Population: mITT subjects who were randomized \& took at least one dose of study medication

PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small \<50% stool/10, small with most stools/20, large \>50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, \>8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score\<10 at Wk 6 (complete) or reduction of \>=20 points baseline to Wk 6 with Wk 6 score\>=10 (partial)

Outcome measures

Outcome measures
Measure	Low Dose n=41 Participants Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)	High Dose n=41 Participants High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	56.1 % participants with treatment success	57.5 % participants with treatment success

Adverse Events

Low Dose

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

High Dose

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose n=50 participants at risk；n=41 participants at risk Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)	High Dose n=41 participants at risk High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)
Infections and infestations Sinusitis	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Gastrointestinal disorders Abdominal Pain	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Investigations Body Mass Index Decreased	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Gastrointestinal disorders Colitis Ulcerative	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)
Infections and infestations Adenovirus Infection	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Gastrointestinal disorders Diarrhoea Haemorrhagic	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Hepatobiliary disorders Cholangitis Sclerosing	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Gastrointestinal disorders Pancreatitis	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Blood and lymphatic system disorders Anaemia	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)
Nervous system disorders Syncope	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)

Other adverse events

Other adverse events
Measure	Low Dose n=50 participants at risk；n=41 participants at risk Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)	High Dose n=41 participants at risk High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-\<33 kg, 33-\<54 kg, 54-90 kg) \& disease severity (mild/moderate)
Gastrointestinal disorders Colitis Ulcerative	10.0% 5/50 • Number of events 5 • Day -7 thru Week 6 of trial (7 weeks)	4.9% 2/41 • Number of events 2 • Day -7 thru Week 6 of trial (7 weeks)
General disorders Fatigue	2.0% 1/50 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)	7.3% 3/41 • Number of events 3 • Day -7 thru Week 6 of trial (7 weeks)
General disorders Pyrexia	0.00% 0/50 • Day -7 thru Week 6 of trial (7 weeks)	7.3% 3/41 • Number of events 3 • Day -7 thru Week 6 of trial (7 weeks)
Infections and infestations Nasopharyngitis	8.0% 4/50 • Number of events 4 • Day -7 thru Week 6 of trial (7 weeks)	9.8% 4/41 • Number of events 4 • Day -7 thru Week 6 of trial (7 weeks)
Infections and infestations Sinusitis	6.0% 3/50 • Number of events 3 • Day -7 thru Week 6 of trial (7 weeks)	0.00% 0/41 • Day -7 thru Week 6 of trial (7 weeks)
Nervous system disorders Dizziness	6.0% 3/50 • Number of events 3 • Day -7 thru Week 6 of trial (7 weeks)	2.4% 1/41 • Number of events 1 • Day -7 thru Week 6 of trial (7 weeks)
Nervous system disorders Headache	8.0% 4/50 • Number of events 4 • Day -7 thru Week 6 of trial (7 weeks)	4.9% 2/41 • Number of events 2 • Day -7 thru Week 6 of trial (7 weeks)

Additional Information

Grexan Wulff, Manager Regulatory Affairs

Warner Chilcott

Phone: 973-442-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60