NCT00476385CompletedPhase 3
Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- practicability/acceptability of the Stylomax pen
Study Overview
Brief Summary
Primary objective:
to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA.
Exclusion Criteria
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
somatropine
Experimental
Intervention: somatropine (Drug)
Outcomes
Primary Outcomes
practicability/acceptability of the Stylomax pen
Time Frame: at each visit
Secondary Outcomes
- tolerability : pain (evaluation on pain scale)(at each visit)
Investigators
Study Sites (1)
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