|
Main
|
|
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 February 2015 |
|
Main ID: |
NCT00468624 |
|
Date of registration:
|
02/05/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Pegvisomant on GH/IGF-I Relationship in GHD
|
|
Scientific title:
|
A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) |
|
Date of first enrolment:
|
December 2004 |
|
Target sample size:
|
|
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00468624 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Peter J Trainer, MD FRCP |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Christie Hospital NHS |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Over 18 years of age
- Confirmed severe AGHD
- GH response <9 mU/l (preferably <4) to insulin-induced hypoglycaemia or glucagon
stimulation test plus (These tests will have taken place as part of routine
management).
- Full, stable pituitary replacement therapy
- Willing to provide informed consent
Exclusion Criteria:
- Unwilling to provide written consent
- Current GH therapy
- Pharmacological doses of glucocorticoids
- Any acute illness
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Severe Adult Growth Hormone Deficiency
|
|
Intervention(s)
|
|
Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks
|
|
Procedure: arginine stimulation test after each limb
|
|
Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo)
|
|
Procedure: blood sampling before and after pegvisomant/placebo
|
|
Primary Outcome(s)
|
|
change in IGF-I
[Time Frame: 2 weeks per limb]
|
|
Secondary Outcome(s)
|
|
change in basal and stimulated GH Change in IGFBP-3 Change in GHBP
[Time Frame: 2 weeks per limb]
|
|
Secondary ID(s)
|
|
04_ENDO_41
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|