Growth Hormone Treatment in Children Born Small for Gestational Age

This study has been completed.

Study NCT00184717 Information provided by Novo Nordisk

First Received on September 13, 2005. Last Updated on January 24, 2012 History of Changes

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Foetal Growth Problem Small for Gestational Age (SGA)
Intervention:	Drug: somatropin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
44 sites in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects completed the main period and were offered to continue in the extension period.

Reporting Groups

	Description
0.033 mg / NN-220	In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
0.067 mg / NN-220	In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
No Treatment	No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
No Treatment --> 0.033 mg	In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
No Treatment --> 0.067 mg	In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Participant Flow for 2 periods

Period 1: Main Period (GHLIQUID-1516)

	0.033 mg / NN-220	0.067 mg / NN-220	No Treatment
STARTED	39	38	21
Exposed to Trial Drug	38	38	21
COMPLETED	36	36	20
NOT COMPLETED	3	2	1

Period 2: Extension Period (GHLIQUID-1517)

	0.033 mg / NN-220	0.067 mg / NN-220	No Treatment	No Treatment --> 0.033 mg	No Treatment --> 0.067 mg
STARTED	33 ^[1]	33 ^[1]	0 ^[2]	10 ^[3]	10 ^[3]
COMPLETED	23	27	0	7	5
NOT COMPLETED	10	6	0	3	5

[1]	Three subjects did not continue in extension period
[2]	Re-randomised to receive 0.033 or 0.067 mg
[3]	Re-randomised from No treatment group

Baseline Characteristics

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Reporting Groups

	Description
0.033 mg / NN-220	In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
0.067 mg / NN-220	In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
No Treatment	No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period

Baseline Measures

	0.033 mg / NN-220	0.067 mg / NN-220	No Treatment	Total
Number of Participants [units: participants]	35	34	15	84
Age [units: years] Mean ± Standard Deviation	5.46 ± 1.37	5.15 ± 1.2	5.09 ± 1.37	5.27 ± 1.3
Gender [units: participants]
Female	11	14	8	33
Male	24	20	7	51
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	35	34	15	84
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0
Asian	35	34	15	84
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0
Region of Enrollment [units: participants]
Japan	35	34	15	84
Height [units: cm] Mean ± Standard Deviation	96.19 ± 8.48	94.57 ± 7.28	94.42 ± 8.48	95.22 ± 7.96
Body weight [units: kg] Mean ± Standard Deviation	13.31 ± 2.55	12.62 ± 1.81	12.47 ± 2.93	12.88 ± 2.36

Outcome Measures

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1. Primary:

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years [ Time Frame: Week 0, week 260 ]

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2. Primary:

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years [ Time Frame: Week 0, week 208 ]

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3. Secondary:

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years [ Time Frame: Weeks 0-260 ]

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4. Secondary:

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years [ Time Frame: Weeks 0-208 ]

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5. Secondary:

Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years [ Time Frame: Week 0, week 260 ]

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6. Secondary:

Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years [ Time Frame: Week 0, week 208 ]

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7. Secondary:

Adverse Events - Subjects Received NN220 Treatment for 5 Years [ Time Frame: Weeks 0-260 ]

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8. Secondary:

Adverse Events - Subjects Received NN220 Treatment for 4 Years [ Time Frame: Weeks 0-208 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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. Restriction Description: Novo Nordisk acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.

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: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184717 History of Changes
Obsolete Identifiers:	NCT00184704
Other Study ID Numbers:	GHLIQUID-1516, GHLIQUID-1517, JapicCTI-050137, JapicCTI-050132
Study First Received:	September 13, 2005
Results First Received:	December 22, 2010
Last Updated:	January 24, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare