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OpenTrials
Completed

NCT Number: NCT00476385

Practicability and Acceptability of Stylomax® in Children

Primary objective:

to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.

Completed

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

somatropine

Drug

subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg

Primary outcomes

  1. practicability/acceptability of the Stylomax pen

    Time frame: at each visit

Secondary outcomes

  1. tolerability : pain (evaluation on pain scale)

    Time frame: at each visit

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.

Important dates

Study start
2003
Primary completion
2005
First posted
May 22, 2007
Registry last updated
Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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