Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Shire

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: MMX Mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01130844

SPD476-112

2011-000164-10 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Enrollment: 52 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
2. Subject has a documented history of ulcerative colitis for at least 3 months.
3. Subjects who are currently on 5-ASA or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product.
4. Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product.
5. Body weight of 18kg-82kg inclusive.

Exclusion criteria

1. Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the IMP, or clinical or laboratory assessments with the exception of their existing ulcerative colitis.
2. Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
3. Any history of hepatic impairment or moderate to severe renal impairment.
4. The use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

MMX Mesalamine (30mg/kg)

Experimental group

Treatment:

Drug: MMX Mesalamine

Drug: MMX Mesalamine

Drug: MMX Mesalamine

MMX Mesalamine (60 mg/kg)

Experimental group

Treatment:

Drug: MMX Mesalamine

Drug: MMX Mesalamine

Drug: MMX Mesalamine

MMX Mesalamine (100 mg/kg)

Experimental group

Treatment:

Drug: MMX Mesalamine

Drug: MMX Mesalamine

Drug: MMX Mesalamine