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Trial record 2 of 2 for:    "Tooth Size" | "tannic acid"

Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00511329
Recruitment Status : Terminated (PI left the institution)
First Posted : August 3, 2007
Results First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Nationwide Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Arthritis, Juvenile Rheumatoid
Crohn Disease
Intervention Drug: somatropin [rDNA origin] for injection
Enrollment 10
Recruitment Details  
Pre-assignment Details PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
Arm/Group Title Somatropin
Hide Arm/Group Description somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title Somatropin
Hide Arm/Group Description somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title The Primary Outcome Variables Will be Height and Weight Z Score.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
Arm/Group Title Somatropin
Hide Arm/Group Description:
somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
Arm/Group Title Somatropin
Hide Arm/Group Description:
somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
 
Arm/Group Title Somatropin
Hide Arm/Group Description somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
All-Cause Mortality
Somatropin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Somatropin
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Somatropin
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie Rice, RN
Organization: Nationwide Children's Hospital
Phone: 6143553142
EMail: julie.rice@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00511329     History of Changes
Other Study ID Numbers: GA628132
First Submitted: August 2, 2007
First Posted: August 3, 2007
Results First Submitted: May 15, 2015
Results First Posted: April 12, 2018
Last Update Posted: April 12, 2018