Atorvastatin for treatment of acute inflammation in newly diagnosed children with Crohn’s disease

Phase 2

• Conditions: Crohn's disease; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12612000129886
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Male or females aged 8 to 17 years
-Diagnosis of crohn’s diease confirmed on clinical,radiological,endoscopic and/or histological criteria and yet to receive treatment

Exclusion Criteria

- Age <8 or > than 17
- Previously treated CD
- Newly diagnosed CD but already commenced any form of therapy for induction of remission including any form of steroid therapy.
- Any underlying chromosomal disorders eg Down’s syndrome, Turner’s syndrome
-Any underlying autoimmune diagnosis eg juvenile arthritis, connective tissue disease, coeliac disease, type 1 diabetes mellitus, addison’s disease, hypothyroidism, hyperthyroidism, polyglandular endocrinopathy.
- Primary bone disorder eg osteogenesis imperfecta
- A secondary chronic medical diagnosis that may have an impact on linear growth and bone health
- Previous adverse reaction to statins
- Current pregnancy or sexually active and not using a medically acceptable form of birth control. (All girls who are menarchal or > 14 years of age will need to undego a pregnancy test before being eligible for the study).
- History of clinically significant organic or psychiatric disease or findings on physical examination, which in the opinion of the Investigator would prevent the patient from completing the study.
- Ongoing use of oral corticosteroid for a different medical condition prior to diagnosis
- Ongoing use of immunomodulators eg azathioprine, methotrexate; biologics eg anti TNF therapy for a different medical condition (to exclude patients with another known chronic inflammatory condition)
- Ongoing use of growth hormone, sex steroid, thyroxine and/or steroid replacement (hydrocortisone, prednisolone, dexamathasone) for an underlying endocrine diagnosis (to exclude conditions like growth hormone deficiency, hypopituitarism)
- Ongoing use of cyclosporine, fibrates, CYP3A4 inhibitors, itraconazole, HIV protease inhibitors (concurrent medication absolutely contraindicated with atovarstatin).
- AST or ALT > 2 x upper limit of normal from investigations performed in the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified