Status:
COMPLETED
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief Summary
This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.Th...
Eligibility Criteria
Inclusion
- Age 3-18 year with a bone age test under 18-year Children with short bowel syndrome and intestinal insufficiency, the remaining bowel length should be under 80 cm after the first post-surgical period.
- Parenteral nutrition dependency: under parenteral nutrition for at least 3 years with parenteral glycolipidic diet \> or = 30% of the total caloric need for age. The parenteral diet should have been stable for at least 3 months.
- Parents consent
Exclusion
- Over 20% change in caloric daily requirement within the last 6 months before inclusion.
- Surgery on digestive tube within the last 3 months. Administration of drugs targeting digestion (decontamination, macrobiotic, gastric dressing, chelating agents of biliary salts) within the last month.
- History or presence of tumoral process, leukaemia, minor intracranial hypertension, epiphysiolysis, carpal tunnel syndrome.
- Ongoing infection (fever and inflammatory biologic syndrome), progressive inflammatory syndrome.
- Heart failure, renal and respiratory insufficiency. Allergy to solvent. Any condition making impossible the follow-up of the patient during the study. Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00169637
Start Date
June 1 2006
End Date
June 1 2008
Last Update
October 31 2008
Active Locations (1)
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1
Alain LACHAUX
Lyon, France, 69437