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

Acromegaly Clinical Trial

— SALSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447499
• Other study ID #: MS315
• Status: Completed
• Phase: Phase 3
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Somatuline Autogel (lanreotide acetate)
Injections

Behavioral:
• Home administration
Questionnaire

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachussetts General Hospital	Boston	Massachusetts
United States	Northwestern University The Feinberg School of Medicine	Chicago	Illinois
United States	Research Institute of Dallas	Dallas	Texas
United States	Denver VA Medical Center	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Diabetes and Endocrine Associates	La Mesa	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Columbia University	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Oregon Health and Science University	Portland	Oregon
United States	Sisters of Charity Hospital, Buffalo	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

References & 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-naïve patients with acromegaly. P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.	Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.	24 weeks
Secondary	Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study	Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.	24 weeks
Secondary	Percentage of Switch Subjects That Have Glucose Suppressed GH Levels = 2.5 ng/ml at the End of the Study, Week 24/Termination.	Blood samples taken before and 60 and 120 min after glucose load from fasting patient.	24 Weeks
Secondary	Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients	Blood samples taken before and 60 and 120 min after glucose load from fasting patient.	24 Weeks
Secondary	Total Symptom Questionnaire Score at Week 24/Termination	Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.	24 Weeks
Secondary	Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination	Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.	24 weeks