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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-000164-10-GB
• Lead Sponsor: Shire Development LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-19
• Study Completion: 2013-06-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Subject’s parent or legally acceptable representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject indicating the subject is aware of the investigational nature of the study, able and willing to participate in the study, and aware of the required restrictions and procedures
2. Males and females aged 5-17 years at the time of the first dose of investigational medicinal product
3. Subject has a documented history of ulcerative colitis for at least 3 months prior to first dose of investigational medicinal product, as confirmed by medical records, a physician referral, similar documentation, or investigator assessment of date of diagnosis, clinical course, history of flares, and prior medications as reported by the subject/parent/LAR
4. Subjects who are currently on a 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. The subject must be willing and the investigator deem it medically acceptable, to replace the current therapy with the investigational medicinal product for the 8-day study treatment period
5. 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 of investigational medicinal product
6. Good general health (except for ulcerative colitis and associated sequelae) based on medical history, vital signs, electrocardiogram, physical examination, and clinical laboratory results at Screening (Days –28 to –2)
7. Body weight of 18kg-82kg inclusive, at Screening (Days –28 to –2) and Baseline (Day –1)

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current or recurrent disease (e.g., cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the investigational medicinal product, 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 as confirmed by medical history
4. History of moderate to severe renal impairment defined as glomerular filtration rate <60ml/min/1.73m2 as confirmed by medical history (based on the Schwartz equation: CrCl (ml/min/1.73m2)= [length (cm) x k] / Scr)
5. A history of allergy, hypersensitivity, or poor tolerability to salicylates or aminosalicylates (5-ASA)
6. Any history of Reyes syndrome
7. Any history of pancreatitis
8. 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
9. Repeated use of any anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs but excluding 5-ASA or products containing or metabolized to mesalamine [oral or rectal]) within 7 days prior to the first dose of investigational medicinal product
10. If anti-diarrheals and/or antispasmodics are being used, subjects need to be on a stable dose regimen for 3 days prior to the first dose of investigational medicinal product
11. Use of another investigational medicinal product within 30 days prior to receiving the first dose of investigational medicinal product or active enrollment in another drug or vaccine clinical trial; concurrent participation in an observational (i.e. Registry) study would not be exclusionary, as long as all other inclusion and exclusion criteria are met
12. Current or relevant history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder (including subjects underlying ulcerative colitis .e.g., concurrent severe flare) that may require new treatment or changes to their current treatment regimen or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational medicinal product or procedures
13. Subjects with asthma are excluded only if they are known to be 5-ASA-sensitive

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified