Brief Title
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Official Title
A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.
Secondary Outcome
Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.
Condition
Acromegaly
Intervention
Somatuline Autogel (lanreotide acetate)
Study Arms / Comparison Groups
Somatuline Autogel (lanreotide acetate)
Description: Somatuline Autogel (lanreotide acetate) Injection
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
59
Start Date
April 2007
Completion Date
December 2008
Primary Completion Date
December 2008
Eligibility Criteria
Inclusion Criteria:
- The subject must give signed informed consent before any study-related activities.
- The partner, if applicable, must give signed informed consent before administration of
Somatuline Autogel.
- The subject must be able to understand the protocol requirements.
- The subject must have a clinical diagnosis of acromegaly due to pituitary tumor.
- The subject must be treated with a long-acting somatostatin analogue with or without a
dopamine agonist and have been on the current medical regimen for at least 3 months
prior to screening and have IGF-1 levels no higher than 10% above the upper limit of
the normal range for age and gender at the screening visit or be somatostatin analogue
naïve (if the subject is treated with a dopamine agonist he/she must have been on the
current dose for at least 3 months prior to screening).
- Subjects who are treated with a dopamine agonist have to stay on their current dose
for the duration of the study.
- Switch subjects must have had their last pre-study routine clinical treatment with
Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).
- The subject must be able to store the study medication in a refrigerator in his/her
own or his/her partner's home.
- The subject must be ≥18 years of age.
- Female subjects of childbearing potential must use adequate contraception.
- Female subjects of childbearing potential who are taking oral contraceptives must
agree to stay on their current contraceptive dose for the duration of the study.
- The partner, if applicable, must be ≥18 years of age.
Exclusion Criteria:
- The subject has had pituitary surgery (adenomectomy) within 3 months prior to
screening.
- The subject has received pituitary radiotherapy within 3 years prior to screening.
- The subject has received a GH receptor antagonist within 6 months prior to screening.
- The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d
- The subject is pregnant or breastfeeding.
- The subject has clinically significant renal or hepatic abnormalities.
- The subject has a symptomatic, untreated biliary lithiasis.
- The subject has uncontrolled diabetes or thyroid disease.
- The subject has a known hypersensitivity to any of the test materials or related
compounds.
- The subject is unable or unwilling to comply with the protocol.
- The subject has received any investigational drug within 30 days prior to screening.
- The subject has participated in a medical device study within 30 days prior to
screening.
- The subject has previously participated in this study.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00447499
Organization ID
MS315
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen (formerly Tercica)
Verification Date
November 2020