Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome - Full Text View

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00169637

Purpose

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.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.

Condition	Intervention	Phase
Short Bowel Syndrome	Drug: rhGH	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months

Secondary Outcome Measures:

Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4) and at the end of study (month 14)
To quantify the variation in body composition (auxology and biphotonic absorptiometry) at the end of the randomized study (month 4) and at the end of study (month 14)
To evaluate the tolerance and safety of rhGH at the end of the randomized study (month 4) and at the end of study (month 14.

Enrollment:	14
Study Start Date:	June 2006
Study Completion Date:	June 2008

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169637

Locations

France
Alain LACHAUX
Lyon, France, 69437

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Alain LACHAUX, MD

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Hospices Civils de Lyon ( Alain Lachaux )
Study ID Numbers:	2002.301
Study First Received:	September 12, 2005
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00169637 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Short bowel syndrome
Growth hormone
Children

Additional relevant MeSH terms:

Disease
Gastrointestinal Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Short Bowel Syndrome
Intestinal Diseases
Hormones

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Postoperative Complications
Syndrome
Malabsorption Syndromes

ClinicalTrials.gov processed this record on November 27, 2009