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Clinical Trials/NCT00174408
NCT00174408CompletedPhase 3

Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)

Pfizer0 sites110 target enrollmentStarted: March 1990Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Pfizer
Enrollment
110
Primary Endpoint
Height, height velocity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Birth length below -2 SD
  • •Height at start below - 2 Sd

Exclusion Criteria

  • •Any endocrine or chronic disease
  • •Any known syndrome with short stature

Outcomes

Primary Outcomes

Height, height velocity

Secondary Outcomes

  • Side effects

Investigators

Sponsor
Pfizer
Sponsor Class
Industry

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