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A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel


Phase 3
18 Years
N/A
Not Enrolling
Both
Acromegaly

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Trial Information

A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Description:

The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Sandra L Blethen, M.D. PhD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen (formerly Tercica)

Authority:

United States: Food and Drug Administration

Study ID:

MS315

NCT ID:

NCT00447499

Start Date:

April 2007

Completion Date:

December 2008

Related Keywords:

  • Acromegaly
  • Acromegaly
  • Somatostatin Analogs
  • Somatuline® Autogel®
  • lanreotide
  • growth hormone
  • IGF-1
  • Inappropriate Growth Hormone Secretion Syndrome
  • Somatotropin Hypersecretion Syndrome
  • Inappropriate GH Secretion Syndrome
  • Acromegaly

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Johns Hopkins UniversityBaltimore, Maryland  21205
Columbia UniversityNew York, New York  10032-3784
University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
Oregon Health and Science UniversityPortland, Oregon  97201
NYU School of MedicineNew York, New York  10016
Denver Va Medical CenterDenver, Colorado  80220
Diabetes and Endocrine AssociatesLa Mesa, California  91942
Northwestern University The Feinberg School of MedicineChicago, Illinois  60611
Massachussetts General HospitalBoston, Massachusetts  02114
Sisters of Charity Hospital, BuffaloWilliamsville, New York  14221
Research Institute of DallasDallas, Texas  75231