Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

EMD Serono

ClinicalTrials.gov Identifier:

NCT00109733

First received: May 2, 2005

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Results First Received: May 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Childhood-onset Growth Hormone Deficiency Pituitary Dwarfism
Intervention:	Biological: recombinant human growth hormone

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Initiation Date: 06 Jan 2005 (date of first subject, first dose) Study Completion Date 11 Jun 2006 (date of last subject, last visit) 19 study centres in the United States received IRB approval to participate in this study; 13 of the centres enrolled at least one subject into the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All study screening assessments were to be performed within a 30-day period prior to study entry. A total of 40 subjects were screened for the study and 31 of them (77.5%) were randomised and received study drug.

Reporting Groups

	Description
Standard Dose Group	0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
High Dose Group	0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.

Participant Flow: Overall Study

	Standard Dose Group	High Dose Group
STARTED	15	16
COMPLETED	13	12
NOT COMPLETED	2	4
Protocol Violation	0	1
Stopped taking study drug	1	1
Non-compliant	0	1
Could not commit time for study	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Standard Dose Group	0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
High Dose Group	0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
Total	Total of all reporting groups

Baseline Measures

	Standard Dose Group	High Dose Group	Total
Number of Participants [units: participants]	15	16	31
Age [units: years] Mean ± Standard Deviation	17.4 ± 1.8	18.1 ± 1.9	17.8 ± 1.9
Gender [units: participants]
Female	5	6	11
Male	10	10	20
Region of Enrollment [units: participants]
United States	15	16	31
Lean body mass [units: kg] Mean ± Standard Deviation	44.03 ± 11.09	44.38 ± 12.98	44.21 ± 11.90
Limb fat [units: kg] Mean ± Standard Deviation	11.47 ± 5.49	12.92 ± 9.28	12.22 ± 7.59
Total body fat [units: kg] Mean ± Standard Deviation	24.02 ± 10.81	25.11 ± 18.29	24.58 ± 14.90
Trunk fat [units: kg] Mean ± Standard Deviation	11.73 ± 5.58	11.40 ± 9.09	11.56 ± 7.47
Trunk to limb fat ratio [units: ratio] Mean ± Standard Deviation	1.05 ± 0.29	0.87 ± 0.17	0.96 ± 0.25

Outcome Measures

Show All Outcome Measures

1. Primary:

Percent Change From Baseline to Week 24 in Trunk Fat [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 1

2. Secondary:

Percent Change From Baseline to Week 24 in Lean Body Mass [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 2

3. Secondary:

Percent Change From Baseline to Week 24 in Total Body Fat [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 3

4. Secondary:

Percent Change From Baseline to Week 24 in Limb Fat [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 4

5. Secondary:

Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Sanja Dragnic/Medical Responsible
Organization: EMD Serono
phone: +7816814017
e-mail: sanja.dragnic@emdserono.com

No publications provided

Responsible Party:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00109733 History of Changes
Other Study ID Numbers:	25253
Study First Received:	May 2, 2005
Results First Received:	May 19, 2010
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration

To Top