Trial Outcomes & Findings for Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis (NCT NCT01004185)
NCT ID: NCT01004185
Last Updated: 2012-05-25
Results Overview
PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount \<50% of stools, small amount most stools, large amount \>50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/\>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Week 26
Results posted on
2012-05-25
Participant Flow
Screening began on 6 Oct 2009
There was a 30-day run-in phase for subjects continuing directly from Study 2007017.
Participant milestones
| Measure |
High Dose
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
High Dose
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Sponsor Terminated Study
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
High Dose
n=19 Participants
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
n=20 Participants
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
13.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
13.1 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Age, Customized
5-8 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
9-17 years
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.
PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount \<50% of stools, small amount most stools, large amount \>50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/\>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.
Outcome measures
| Measure |
High Dose
n=19 Participants
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
n=20 Participants
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
|
53.3 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.
PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount \<50% of stools, small amount most stools, large amount \>50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/\>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission \<10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.
Outcome measures
| Measure |
High Dose
n=19 Participants
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
n=20 Participants
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
|
60 percentage of participants
|
60 percentage of participants
|
Adverse Events
High Dose
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dose
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose
n=19 participants at risk
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
n=20 participants at risk
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • Number of events 2 • 18 months
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
Other adverse events
| Measure |
High Dose
n=19 participants at risk
Subjects who weigh 17-\<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 4.8 g/day Asacol.
|
Low Dose
n=20 participants at risk
Subjects who weigh 17-\<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-\<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-\<90 kg will receive 2.4 g/day Asacol.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • 18 months
|
10.0%
2/20 • 18 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • 18 months
|
15.0%
3/20 • 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • 18 months
|
10.0%
2/20 • 18 months
|
|
General disorders
Axillary Pain
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Gastrointestinal disorders
Cyst
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Infections and infestations
Cellulitis Orbital
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Infections and infestations
Ear Infection
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Infections and infestations
Infectious Mononucleosis
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Infections and infestations
Sinusitis
|
15.8%
3/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.5%
2/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Infections and infestations
Viral Infection
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Investigations
Lipase Increased
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Investigations
Stool Analysis Abnormal
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Investigations
Urinary Sediment Present
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Renal and urinary disorders
Proteinuria
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.3%
1/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
1/19 • 18 months
|
0.00%
0/20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin Erosion
|
0.00%
0/19 • 18 months
|
5.0%
1/20 • 18 months
|
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