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

NCT01004185 | Terminated Phase 3 Results

• 1 other identifier: 2008085
• Study Type: interventional
• Target: 39
• Locations: 6 countries
• Sites: 51

Brief Summary

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 26

Secondary Outcomes (1)

• Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT

  Week 26

Study Arms (2)

High Dose

EXPERIMENTAL

2.0 - 4.8 g/day Asacol dependent on body weight

Drug: Asacol 400 mg

Low Dose

EXPERIMENTAL

1.2 - 2.4 g/day Asacol dependent upon body weight

Drug: Asacol 400 mg

Interventions

Asacol 400 mg DRUG

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

Also known as: mesalamine; 5-aminosalicylic acid; 5-ASA; mesalazine

High Dose

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[at least 3 months prior to enrollment\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (51)

Research Site

Birmingham, Alabama, 35233, United States

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Phoenix, Arizona, 85016, United States

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Loma Linda, California, 92354, United States

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San Diego, California, 92123, United States

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San Francisco, California, 94118, United States

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San Francisco, California, 94143, United States

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Gainesville, Florida, 32601, United States

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Miami, Florida, 33155, United States

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Park Ridge, Illinois, 60068, United States

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Louisville, Kentucky, 40202, United States

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Portland, Maine, 04102, United States

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Boston, Massachusetts, 02114, United States

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Worcester, Massachusetts, 01655, United States

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Southfield, Michigan, 48075, United States

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Jackson, Mississippi, 39202, United States

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Kansas City, Missouri, 64108, United States

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Las Vegas, Nevada, 89109, United States

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Mays Landing, New Jersey, 08330, United States

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Buffalo, New York, 14222, United States

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New Hyde Park, New York, 11040, United States

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Providence, Rhode Island, 02903, United States

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Nashville, Tennessee, 37232, United States

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Fort Worth, Texas, 76104, United States

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San Antonio, Texas, 78229, United States

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Huntington, West Virginia, 25701, United States

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Edmonton, Alberta, T6G 2J3, Canada

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Halifax, Nova Scotia, B3K 6R8, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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London, Ontario, N6A 5W9, Canada

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Ottawa, Ontario, K1H 8L1, Canada

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Rijeka, Croatia

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Zagreb, Croatia

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Bialystok, 15-274, Poland

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Bydgoszcz, 85-094, Poland

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Katowice, 40-752, Poland

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Krakow, 30-663, Poland

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Lodz, 91-738, Poland

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Warsaw, 04-730, Poland

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Wroclaw, 50-369, Poland

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Bucharest, 00 17 43, Romania

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Bucharest, 04 14 51, Romania

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Iași, 70 03 09, Romania

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Kazan', 420138, Russia

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Moscow, 103001, Russia

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Moscow, 105077, Russia

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Moscow, 117963, Russia

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Moscow, 119021, Russia

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Moscow, 127412, Russia

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Nizhny Novgorod, 603950, Russia

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Novosibirsk, 630091, Russia

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Smolensk, 214019, Russia

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MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Grexan Wulff, Manager Regulatory Affairs
• Organization: Warner Chilcott

gwulff@wcrx.com

973-442-3376

Study Officials

• Herman Ellman, MD

  Warner Chilcott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 25, 2012
• Results First Posted: May 25, 2012

Record last verified: 2012-04

Locations

RU (9); US (25); PL (7); CR (2); CA (5); RO (3)