Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00630487

First received: February 28, 2008

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Results First Received: August 3, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Growth Hormone Deficiency
Interventions:	Drug: Placebo 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
Study Initiation and Completion Dates: 26 May 2008 to 17 October 2008. The study was terminated prematurely.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Nine patients were enrolled, but no patients were randomized due to early termination of study.

Reporting Groups

	Description
Placebo	No text entered.
Somatropin	Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.

Participant Flow: Overall Study

	Placebo	Somatropin
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Somatropin	Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Somatropin	Total
Number of Participants [units: participants]	0	0	0
Age [units: participants]
<=18 years
Between 18 and 65 years
>=65 years
Gender [units: participants]
Female
Male

Outcome Measures

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1. Primary:

Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI) [ Time Frame: Baseline, 52 weeks ]

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2. Secondary:

Change in Visceral Fat Mass in Subgroups [ Time Frame: Baseline, 52 weeks, 78 weeks ]

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3. Secondary:

Change From Baseline in Anthropometric Parameters (Height) [ Time Frame: Baseline, 52 weeks, 78 weeks ]

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4. Secondary:

Change From Baseline in Anthropometric Parameters (Weight) [ Time Frame: Baseline, 52 weeks, 78 weeks ]

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5. Secondary:

Change From Baseline in Anthropometric Parameters (Waist Circumference) [ Time Frame: Baseline, 52 weeks, 78 weeks ]

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6. Secondary:

Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT]) [ Time Frame: Baseline, Week 52, Week 78 ]

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7. Secondary:

Change From Baseline in Blood Pressure [ Time Frame: Baseline, Week 52, Week 78 ]

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8. Secondary:

Change From Baseline in Heart Rate [ Time Frame: Baseline, Week 52, Week 78 ]

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9. Secondary:

Change in Executive Function and Memory in Subgroups [ Time Frame: Baseline, Week 52, Week 78 ]

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10. Secondary:

Change From Baseline in Safety Laboratory Assessments [ Time Frame: Baseline, Week 52, Week 78 ]

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11. Secondary:

Change From Baseline in Homeostasis Model Assessment (HOMA)-Index [ Time Frame: Baseline, Week 52, Week 78 ]

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12. Secondary:

Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) [ Time Frame: Baseline, Week 52, Week 78 ]

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13. Secondary:

Change From Baseline in Short Form (36) Health Survey (SF36) [ Time Frame: Baseline, Week 52, Week 78 ]

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14. Secondary:

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) [ Time Frame: Baseline, Week 52, Week 78 ]

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15. Secondary:

Change From Baseline in Cardiovascular Risk Factors [ Time Frame: Baseline, Week 52, Week 78 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Cardiovascular Risk Factors
Measure Description	Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)
Time Frame	Baseline, Week 52, Week 78
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	No text entered.
Somatropin	Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.

Measured Values

	Placebo	Somatropin
Number of Participants Analyzed [units: participants]	0	0
Change From Baseline in Cardiovascular Risk Factors

No statistical analysis provided for Change From Baseline in Cardiovascular Risk Factors

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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00630487 History of Changes
Other Study ID Numbers:	A6281282
Study First Received:	February 28, 2008
Results First Received:	August 3, 2010
Last Updated:	February 26, 2013
Health Authority:	Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

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