The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM
17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo PM; 54-\<90kg = 3 Asacol 400mg \& 3 placebo AM \& PM
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population
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.
Time frame: Week 26
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT
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.
Time frame: Week 26
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Research Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Loma Linda, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Park Ridge, Illinois, United States
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Louisville, Kentucky, United States
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