Clinical trial NCT00447499: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
Somatostatin Analogs
Somatuline® Autogel®
lanreotide
growth hormone
IGF-1
Inappropriate Growth Hormone Secretion Syndrome
Somatotropin Hypersecretion Syndrome
Inappropriate GH Secretion Syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.
timeFrame: 24 weeks
measure: Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study
timeFrame: 24 weeks
measure: Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.
timeFrame: 24 Weeks
measure: Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients
timeFrame: 24 Weeks
measure: Total Symptom Questionnaire Score at Week 24/Termination
timeFrame: 24 Weeks
measure: Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination
timeFrame: 24 weeks
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern University The Feinberg School of Medicine
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Williamsville
country: United States
facility: Sisters of Charity Hospital, Buffalo
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Ipsen (formerly Tercica)
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Salvatori R, Nachtigall LB, Cook DM, Bonert V, Molitch ME, Blethen S, Chang S; SALSA Study Group. Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naive patients with acromegaly. Pituitary. 2010 Jun;13(2):115-22. doi: 10.1007/s11102-009-0207-x.