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Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Fetal Growth Retardation

Treatments

Drug: Genotonorm (Somatropin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174252
A6281234

Details and patient eligibility

About

To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Enrollment

57 patients

Sex

All

Ages

4 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
  • Measured Height < -2.5 Standard Deviation

Exclusion criteria

  • Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2 (Tanner)
  • Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Genotonorm (Somatropin)
Experimental group
Treatment:
Drug: Genotonorm (Somatropin)

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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