PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000356-17-DK
• Date of registration: 29/11/2004
• Prospective Registration: Yes
• Primary sponsor: Beaufour Ipsen Pharma
• Public title: PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima
• Scientific title: PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD - Optima
• Date of first enrolment: 19/04/2005
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000356-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Denmark, Finland, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Children (boys and girls under 18) with growth failure associated with:
- inadequate growth hormone secretion
- Turner syndrome, confirmed by karyotype
- chronic renal insufficiency up to renal transplantation
Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable AND the child when applicable

Are the trial subjects under 18? yes
Number of subjects for this age range:
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:
Children with hypersensitivity to somatropin or any of the excipients
Children with closed epiphyses
Children with active neoplasm
Children with acute critical illness due to surgery, multiple accidental trauma
Children with acute respiratory failure
Children having received any unlicensed drug within the previous 30 days



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI). NutropinAq™ is given as a daily subcutaneous injection dose: GDH: 0,025- 0,035 mg/kg/day, TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day. No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction.
MedDRA version: 7.0 Classification code 10056438

Intervention(s)

Trade Name: NutropinAq
Product Name: NutropinAq
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Other descriptive name: Somatropin (INN) recombinant DNA orgin, Escherichia coli
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal

Primary Outcome(s)

Secondary Objective: The factors affecting the variability of capillary IGF-I measurements; i.e. to establish whether the variability of IGF-I levels is homogeneously distributed in the patient population and/or if individual factors affect the day to day variability of IGF-I levels.

The precision profile of capillary vs plasma IGF-I measurements.

The auxological parameters during NutropinAq treatment: changes in height, weight, growth velocity and height standard deviation score at each visit (M3 & M6).

The acceptability of the NutropinAq Pen by a questionnaire administered at M5.

Main Objective: The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients

Primary end point(s): The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients

Secundary end points:

The factors affecting the variability of capillary IGF-I measurements; i.e. to establish whether the variability of IGF-I levels is homogeneously distributed in the patient population and/or if individual factors affect the day to day variability of IGF-I levels.

The precision profile of capillary vs plasma IGF-I measurements.

The auxological parameters during NutropinAq treatment: changes in height, weight, growth velocity and height standard deviation score at each visit (M3 & M6).

The acceptability of the NutropinAq Pen by a questionnaire administered at M5.

Secondary ID(s)

2004-000356-17-IT

2-79-58035-700