Trial · Interventional

CompletedPhase 3Results postedRegistry data

Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Short name Phoenix

NCTNCT00355030Other id9861Other idB9R-FP-GDGI

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 91 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 2 countries
France, Netherlands
Start: Jun 2006
Primary completion: Jul 2015
Completion: Jul 2015
First posted: 20 Jul 2006 (estimated)
Last update posted: 30 Sept 2019
Conditions: Idiopathic Short Stature (ISS)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200620082010201220142016

Ph 3
Phoenix
NCT00355030
Jun 2006 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods. Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

Interventions

somatropinDrug
leuprorelinDrug

Arms2

Experimental
1
Experimental
2

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Participants With One or More Drug-related Adverse Events
Time frame · Baseline through End of Study (up to 9 years)
Registry description
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Adult Height Standard Deviation Score (SDS)
Time frame · Baseline through End of Study (up to 9 years)
Registry description
The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.

Secondary outcomes(7)

Height Velocity
Time frame · Baseline through End of Study (up to 9 years)
Registry description
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Height SDS
Time frame · Baseline through End of Study (up to 9 years)
Registry description
SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Difference Between Adult Height SDS and Target Height SDS
Time frame · Baseline through End of Study (up to 9 years)
Registry description
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height \[calculated as (mother's height (SDS) + father's height (SDS))/2\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Difference Between Adult Height SDS and Baseline Predicted Height SDS
Time frame · Baseline through End up Study (up to 9 years)
Registry description
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height \[calculated using the Bayley-Pinneau method based on height and bone age\] for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Difference Between Adult Height SDS and Baseline Height SDS
Time frame · Baseline through End up Study (up to 9 years)
Registry description
This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant. The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Percentage of Children With Normal Adult Height SDS
Time frame · Baseline through End of Study (up to 9 years)
Registry description
Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)
Bone Age
Time frame · Baseline through End of Study (up to 9 years)
Registry description
Bone age measured using the X-Ray of left hand and wrist.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline through End of Study (up to 9 years)

Number of Participants With One or More Drug-related Adverse Events

Group	Value (participants)
Somatropin and Leuprorelin	42
Somatropin	38

Primary outcomeMean· Baseline through End of Study (up to 9 years)

Adult Height Standard Deviation Score (SDS)

Group	Value (standard deviation score)	Spread
Somatropin and Leuprorelin	-1.8	0.53
Somatropin	-1.9	0.77

Secondary and other outcome results(6)

Secondary outcomeMean· Baseline through End of Study (up to 9 years)

Height Velocity

Group	Value (centimeter per year)	Spread
Somatropin and Leuprorelin	7.8	6.92
Somatropin	7.4	6.03

Secondary outcomeMean· Baseline through End of Study (up to 9 years)

Height SDS

Group	Value (standard deviation score)	Spread
Somatropin and Leuprorelin	-2.5	0.45
Somatropin	-2.5	0.46

Secondary outcomeMean· Baseline through End of Study (up to 9 years)

Difference Between Adult Height SDS and Target Height SDS

Group	Value (standard deviation score)	Spread
Somatropin and Leuprorelin	-0.6	0.89
Somatropin	-1.2	0.80

Secondary outcomeMean· Baseline through End up Study (up to 9 years)

Difference Between Adult Height SDS and Baseline Predicted Height SDS

Group	Value (standard deviation score)	Spread
Somatropin and Leuprorelin	1.1	0.96
Somatropin	1.2	0.70

Secondary outcomeMean· Baseline through End up Study (up to 9 years)

Difference Between Adult Height SDS and Baseline Height SDS

Group	Value (standard deviation score)	Spread
Somatropin and Leuprorelin	0.6	0.59
Somatropin	0.6	0.67

Secondary outcomeNumber· Baseline through End of Study (up to 9 years)

Percentage of Children With Normal Adult Height SDS

Group	Value (percentage of participants)
Somatropin and Leuprorelin	26.7
Somatropin	25.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Somatropin and LeuprorelinSomatropin and leuprorelin n=46	–	12 / 46	41 / 46
SomatropinSomatropin n=45	–	7 / 45	36 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 8 Years up to 171 Months
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * male or female children with ISS * age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys * bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist * Pubertal stage B2 and B3 for girls based on the Tanner method * Pubertal stage G2 and G3 for boys based on the Tanner method Exclusion Criteria: * Growth hormone deficiency (GHD) * Insulin-like growth factor-I levels greater than 3 SDS * Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory * Small for gestational age (SGA) * Has reached menarche (had her first menstrual period) * Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment

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