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Trial record 43 of 821 for:    SOMATROPIN

Growth Hormone Therapy for Wasting in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00803179
Recruitment Status : Terminated (Poor enrollment, patients were lost to follow up)
First Posted : December 5, 2008
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Stalvey, University of Massachusetts, Worcester

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Intervention: Drug: Nutropin AQ

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Growth Hormone Therapy

Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d


Participant Flow:   Overall Study
    Growth Hormone Therapy
STARTED   5 
COMPLETED   2 
NOT COMPLETED   3 
Lost to Follow-up                3 



  Baseline Characteristics

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
Growth Hormone Therapy

Nutropin AQ:

Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d


Baseline Measures
   Growth Hormone Therapy 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   0 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy   [ Time Frame: 14 months ]

2.  Secondary:   Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy   [ Time Frame: 14 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Stalvey, MD, Principal Investigator
Organization: UMass Medical School
phone: 508-856-4280
e-mail: mstalvey@peds.uab.edu



Responsible Party: Michael Stalvey, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00803179     History of Changes
Other Study ID Numbers: 900005
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: November 13, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 15, 2013