Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

Inclusion Criteria

male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication;
have a documented history of UC that has been successfully maintained in complete remission for at least 1 month prior to study entry
have a baseline PUCAI score < 10
have a body weight no less than 17 kg and no more than 90 kg
have a history of at least 1 active episode or relapse in the last 12 months
have taken a stable maintenance dose of oral mesalamine (or equivalent oral 5-ASA dose) for at least 1 month prior to entry in the study. Stable is defined as the same dose for the last month.
maintained complete remission, as defined, throughout the 30-day run-in phase. Note:ONLY applies to those patients who complete the 6-week treatment in complete remission from Study 2007017 and immediately roll-over to the 30-day run-in phase
are female patients who are pre-menarchal or have a negative urine pregnancy test and, if sexually active, practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]

Exclusion Criteria

have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet
have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures
have a history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome
any "condition" causing "malabsorption" or an effect on gastrointestinal "motility"
have current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is > 1.5 times the upper limit of the age appropriate normal
have a documented history of or current hepatic disease, or liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], total bilirubin) that are > 2 times the upper limit of normal
have a history of pancreatitis
have undergone treatment with any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days prior to the Screening visit
have undergone treatment with any rectal mesalamine therapy within 30 days prior to the screening visit
have undergone treatment with immunomodulatory therapy including, but not limited to: rosiglitazone, 6-mercaptopurine or azathioprine, cyclosporine, or methotrexate within 90 days prior to Screening visit
have undergone treatment with biologic therapy including, but not limited to: infliximab,adalimumab, certolizumab or other biologic treatment of ulcerative colitis within 90 days prior to Screening visit
have undergone treatment with antibiotics (other than topical antibiotics) including metronidazole within 7 days prior to the Screening visit
have undergone treatment with aspirin or other nonsteroidal anti-inflammatory drugs NSAIDs) within 7 days prior to the Screening visit
have undergone treatment with any antidiarrheals and/or antispasmodics within 30 days of the Screening visit
have a stool examination positive for Clostridium difficile (C. difficile), bacterial pathogens, or ova and parasites. Note: Because normal gut flora may vary by geography, the Medical Monitor should be consulted before excluding a patient with a stool sample that is positive for C. difficile, bacterial pathogens or ova and parasites.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose	Asacol 400 mg	2.0 - 4.8 g/day Asacol dependent on body weight
Low Dose	Asacol 400 mg	1.2 - 2.4 g/day Asacol dependent upon body weight

Primary Outcome Measures

Name	Time	Method
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population	Week 26	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	Week 26	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.

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts