Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT01073605

First received: February 22, 2010

Last updated: November 8, 2010

Last verified: February 2010

History of Changes

Results First Received: May 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Growth Disorders Intrauterine Growth Retardation
Intervention:	Drug: Genotonorm

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Genotonorm 0.7 (Continuous Treatment)	Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
Genotonorm 1.4 (Continuous Treatment)	Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
Genotonorm 1.4 (Intermittent Treatment)	Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.

Participant Flow: Overall Study

	Genotonorm 0.7 (Continuous Treatment)	Genotonorm 1.4 (Continuous Treatment)	Genotonorm 1.4 (Intermittent Treatment)
STARTED	68	71	69
Received Treatment	68	70	68
COMPLETED	6 ^[1]	4 ^[1]	8 ^[1]
NOT COMPLETED	62	67	61
Ongoing at Cutoff Date	1	1	0
Adverse Event	2	1	0
Lost to Follow-up	3	4	9
Unknown	25	21	29
Withdrawal by Subject	31	39	22
Randomized But Not Treated	0	1	1

[1]	Corresponds to follow-up until final height

Baseline Characteristics

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Reporting Groups

	Description
Genotonorm 0.7 (Continuous Treatment)	Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
Genotonorm 1.4 (Continuous Treatment)	Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
Genotonorm 1.4 (Intermittent Treatment)	Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
Total	Total of all reporting groups

Baseline Measures

	Genotonorm 0.7 (Continuous Treatment)	Genotonorm 1.4 (Continuous Treatment)	Genotonorm 1.4 (Intermittent Treatment)	Total
Number of Participants [units: participants]	68	70	68	206
Age, Customized [units: Participants]
< 4 years	15	8	6	29
4 - 8 years	29	32	29	90
8 - 12 years	23	30	33	86
>= 12 years	1	0	0	1
Gender [units: Participants]
Female	25	31	39	95
Male	43	39	29	111

Outcome Measures

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1. Primary:

Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm [ Time Frame: Baseline, 2 years ]

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2. Secondary:

Annual Growth Rate Standard Deviation Score (SDS) [ Time Frame: Baseline, 1 to 6 years ]

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3. Secondary:

Change From Baseline in Annual Growth Rate SDS [ Time Frame: Baseline, 1 to 3 years ]

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4. Secondary:

Height (cm) [ Time Frame: Baseline, 1 to 6 years, final height ]

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5. Secondary:

Change From Baseline in Height (cm) [ Time Frame: Baseline, 1 to 6 years, final height ]

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6. Secondary:

Height (SDS) [ Time Frame: Baseline, 1 to 6 years, final height ]

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7. Secondary:

Change From Baseline in Height (SDS) [ Time Frame: Baseline, 1 to 6 years, final height ]

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8. Secondary:

Body Mass Index (BMI) [ Time Frame: Baseline, 1 to 6 years ]

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9. Secondary:

Weight [ Time Frame: Baseline, 1 to 6 years ]

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10. Secondary:

Change From Baseline in Bone Age [ Time Frame: Baseline, 1 to 3 years ]

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11. Secondary:

Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio [ Time Frame: 1 to 3 years ]

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12. Secondary:

Chronological Age at Onset of Puberty [ Time Frame: Onset of puberty ]

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13. Secondary:

Number of Subjects Reaching Puberty [ Time Frame: Baseline, 1 to 6 years ]

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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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01073605 History of Changes
Other Study ID Numbers:	93-8122-001, A6281186, CTN 93-8122-001
Study First Received:	February 22, 2010
Results First Received:	May 6, 2010
Last Updated:	November 8, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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