Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel - Full Text View

Sponsors and Collaborators:	Tercica Ipsen
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00447499

Purpose

The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

Condition	Intervention	Phase
Acromegaly	Drug: Somatuline Autogel (lanreotide acetate) Behavioral: Home administration	Phase III

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin Somatostatin Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

Further study details as provided by Tercica:

Primary Outcome Measures:

The percentage of subjects or their partners that are competent to self-administer Somatuline Autogel at the end of the study, Visit 5, as assessed by the competence questionnaire score. [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of switch subjects who find self-administration of Somatuline Autogel convenient as assessed by the subject convenience questionnaire score. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Percentage of switch subjects that have IGF-1 levels within the normal range for age and gender at the end of the study [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Percentage of switch subjects that have glucose suppressed GH levels ≤ 2.5 ng/ml at the end of the study [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
IGF-1 and GH concentration levels [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Symptom questionnaire score [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Health care professional convenience questionnaire score [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Physical examinations [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Safety laboratory examinations (CBC, serum chemistries, thyroid functions) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment:	59
Study Start Date:	April 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Injections

Questionnaire

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447499

Locations

United States, California
Diabetes and Endocrine Associates
La Mesa, California, United States, 91942
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Illinois
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia University
New York, New York, United States, 10032
Sisters of Charity Hospital, Buffalo
Williamsville, New York, United States, 14221
NYU School of Medicine
New York, New York, United States, 10010
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Research Institute of Dallas
Dallas, Texas, United States, 75231
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77230
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Tercica

Ipsen

Investigators

Study Director:

Sandra L Blethen, M.D. PhD

Tercica, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Tercica ( Sandra Blethen, MD, PhD )
Study ID Numbers:	MS315
Study First Received:	March 12, 2007
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00447499
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

Acromegaly
Somatostatin Analogs
Somatuline® Autogel®
lanreotide
growth hormone

IGF-1
Inappropriate Growth Hormone Secretion Syndrome
Somatotropin Hypersecretion Syndrome
Inappropriate GH Secretion Syndrome

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Angiopeptin
Brain Diseases

Bone Diseases
Somatostatin
Lanreotide
Musculoskeletal Diseases
Endocrinopathy
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009