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OpenTrials
Completed

NCT Number: NCT00191074

Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.

All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.

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Key information

Conditions

Growth Disorder Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bethesda, Maryland, 20892, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participation in core, blinded phase and ability to be contacted by investigators.

For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.

Exclusion criteria

Diabetes mellitus.

History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.

Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.

Treatment and study plan

somatropin, rDNA origin, for injection

Drug

Primary outcomes

  1. Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.

  2. Every year: arm span measurements, head circumference measurements, x-ray for bone age, and

  3. laboratory blood draws.

Secondary outcomes

  1. Not applicable for Amendment (g).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

Important dates

Study start
2001
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Mar 9, 2007

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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