Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

NCT00447499 | Completed Phase 3 Results

• 1 other identifier: MS315
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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').

  24 weeks

Secondary Outcomes (6)

• Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.

  24 weeks

• Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study

  24 weeks

• Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.

  24 Weeks

• Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients

  24 Weeks

• Total Symptom Questionnaire Score at Week 24/Termination

  24 Weeks

Study Arms (1)

Somatuline Autogel (lanreotide acetate)

EXPERIMENTAL

Somatuline Autogel (lanreotide acetate) Injection

Drug: Somatuline Autogel (lanreotide acetate); Behavioral: Home administration

Interventions

Somatuline Autogel (lanreotide acetate) DRUG

Injections

Somatuline Autogel (lanreotide acetate)

Home administration BEHAVIORAL

Questionnaire

Somatuline Autogel (lanreotide acetate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (13)

Diabetes and Endocrine Associates

La Mesa, California, 91942, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Northwestern University The Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

NYU School of Medicine

New York, New York, 10010, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Sisters of Charity Hospital, Buffalo

Williamsville, New York, 14221, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77230, United States

Location

Related Publications (1)

• 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.

  PMID: 19898989 RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Bert Bakker, MD, PhD.
• Organization: Ipsen

bert.bakker@ipsen.com

+1 650 238 1669

Study Officials

• Ipsen Medical Director

  Ipsen (formerly Tercica)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 20, 2020
• Results First Posted: December 20, 2010

Record last verified: 2020-11

Locations

US (13)