Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447499
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2007-03-12
Brief Title:
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALSA
Brief Summary:
The purpose of this study is to determine whether subjects with acromegaly or their partners are able to self administer Somatuline Autogel at home
Detailed Description:
Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option
Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection
Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic If Somatuline Autogel can be safely administered unsupervised while maintaining disease control this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic
This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values
Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection
Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic If Somatuline Autogel can be safely administered unsupervised while maintaining disease control this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic
This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None