Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

NCT ID: NCT00396097

Last Updated: 2016-04-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-08-31

Brief Summary

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To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Detailed Description

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Conditions

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Idiopathic Short Stature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

Standard daily HGH treatment

Group Type ACTIVE_COMPARATOR

Genotropin

Intervention Type DRUG

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Formula-based

Formula-based dose regimen

Group Type ACTIVE_COMPARATOR

Genotropin

Intervention Type DRUG

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Interventions

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Genotropin

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Intervention Type DRUG

Genotropin

Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
* Naive to Growth Hormone treatment

Exclusion Criteria

* Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Arkansas Children's Hospital

Little Rock, Alaska, United States

Site Status

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status

Pediatric Endocrinology of San Diego Medical Group Incorporated

San Diego, California, United States

Site Status

Childrens Hospital Colorado

Aurora, Colorado, United States

Site Status

Memorial Pediatric Specialty Clinic

Colorado Springs, Colorado, United States

Site Status

Pediatric Endocrine Associates

Greenwood Village, Colorado, United States

Site Status

Pediatric Endocrine Associates at The Longmont Clinic

Longmont, Colorado, United States

Site Status

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status

Miller School Of Medicine, University of Miami/Jackson Memorial Medical Center

Miami, Florida, United States

Site Status

Pediatric Endocrinology Associates

Miami, Florida, United States

Site Status

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Site Status

Nemours Children's Clinic

Orlando, Florida, United States

Site Status

Nancy Wright, MD

Tallahassee, Florida, United States

Site Status

University of Iowa Children's Hospital

Iowa City, Iowa, United States

Site Status

University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status

Johns Hopkins Pediatric Endocrinology

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Children's Hospital

Boston, Massachusetts, United States

Site Status

Baystate Medical Center Children's Hospital

Springfield, Massachusetts, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Children's Endocrine Care of St. Louis, LLC

St Louis, Missouri, United States

Site Status

Saint Barnabas Ambulatory Care Center

Livingston, New Jersey, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Women & Children's Hospital of Buffalo

Buffalo, New York, United States

Site Status

The Steven and Alexandra Cohen Children's Medical Center of New York (CCMC)

Lake Success, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Diabetes & Endocrine Center for Children & Young Adults at Phelps Memorial Hospital

Sleepy Hollow, New York, United States

Site Status

Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Central Ohio Pediatric Endocrinology/Diabetes Services (COPEDS)

Columbus, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Pediatric Alliance, PC

Pittsburgh, Pennsylvania, United States

Site Status

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

The Endocrine Clinic P.C.

Memphis, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Ellen Sher, MD PA

Dallas, Texas, United States

Site Status

Children's Medical Center

Dallas, Texas, United States

Site Status

Cooks Children Medical Center/Dept. of Pediatric Endocrinology

Fort Worth, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A6281280

Identifier Type: -

Identifier Source: org_study_id

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