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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00601419
Date of registration:	15/01/2008
Prospective Registration:	No
Primary sponsor:	Pfizer
Public title:	Drug Use Investigation of Somatropin for GHD-ADULTS.
Scientific title:	Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
Date of first enrolment:	March 2007
Target sample size:	230
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00601419
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

The patients who were administered Somatropin to treat "Adult growth hormone deficiency
(limited to severe type)".

Exclusion Criteria:

Patients not administered Somatropin.

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dwarfism, Growth Hormone Deficiency

Intervention(s)

Drug: Somatropin

Primary Outcome(s)

Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. [Time Frame: 6 month]

Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. [Time Frame: 6 month]

Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. [Time Frame: 6 month]

Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. [Time Frame: 6 month]

Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. [Time Frame: 6 month]

Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. [Time Frame: 6 month]

Number of Participants With Treatment Related Adverse Events. [Time Frame: 6 month]

Proportion of Participants Achieving Clinical Efficacy. [Time Frame: 6 month]

Proportion of Participants Achieving Clinical Efficacy by Gender. [Time Frame: 6 month]

Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. [Time Frame: 6 month]

Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. [Time Frame: 6 month]

Secondary Outcome(s)

Secondary ID(s)

A6281286

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	06/02/2014
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00601419

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