Pharmacokinetic studies of recombinant human insulin-like growth factor-I (rhIGF-I) in children with Crohn?s disease induced growth retardatio

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Digestive System; Crohn's disease [regional enteritis]

• Registration Number: ISRCTN81027773
• Lead Sponsor: Queen Mary's School of Medicine and Dentistry (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Criteria for aims 1 and 2:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin greater than 40 g/l
6. Stool alpha-1-antitrypsin concentration:less than 2.0 g/l

Criteria for aim 3:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin less than 35 g/l
6. Stool alpha-1-antitrypsin concentration: greater than 2.3 g/l
7. No corticosteroids for 3 months

Exclusion Criteria

1. Neoplasia
2. Fused epiphyses
3. Corticosteroids within last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IGF-I levels

Secondary Outcome Measures

Name	Time	Method
Blood glucose and hormones of the IGF-I axis