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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Somatuline Autogel (lanreotide acetate)
Home administration
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, Somatostatin Analogs, Somatuline® Autogel®, lanreotide, growth hormone, IGF-1, Inappropriate Growth Hormone Secretion Syndrome, Somatotropin Hypersecretion Syndrome, Inappropriate GH Secretion Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Diabetes and Endocrine Associates
  • Cedars Sinai Medical Center
  • Denver VA Medical Center
  • Northwestern University The Feinberg School of Medicine
  • Johns Hopkins University
  • Massachussetts General Hospital
  • NYU School of Medicine
  • Columbia University
  • Sisters of Charity Hospital, Buffalo
  • Oregon Health and Science University
  • Research Institute of Dallas
  • Baylor College of Medicine
  • University of Texas M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Somatuline Autogel (lanreotide acetate)

Arm Description

Somatuline Autogel (lanreotide acetate) Injection

Outcomes

Primary Outcome Measures

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').

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 12, 2007
Last Updated
November 4, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00447499
Brief Title
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Acronym
SALSA
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, Somatostatin Analogs, Somatuline® Autogel®, lanreotide, growth hormone, IGF-1, Inappropriate Growth Hormone Secretion Syndrome, Somatotropin Hypersecretion Syndrome, Inappropriate GH Secretion Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatuline Autogel (lanreotide acetate)
Arm Type
Experimental
Arm Description
Somatuline Autogel (lanreotide acetate) Injection
Intervention Type
Drug
Intervention Name(s)
Somatuline Autogel (lanreotide acetate)
Intervention Description
Injections
Intervention Type
Behavioral
Intervention Name(s)
Home administration
Intervention Description
Questionnaire
Primary Outcome Measure Information:
Title
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.
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').
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.
Description
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.
Time Frame
24 weeks
Title
Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study
Description
Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.
Time Frame
24 weeks
Title
Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.
Description
Blood samples taken before and 60 and 120 min after glucose load from fasting patient.
Time Frame
24 Weeks
Title
Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients
Description
Blood samples taken before and 60 and 120 min after glucose load from fasting patient.
Time Frame
24 Weeks
Title
Total Symptom Questionnaire Score at Week 24/Termination
Description
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.
Time Frame
24 Weeks
Title
Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen (formerly Tercica)
Official's Role
Study Director
Facility Information:
Facility Name
Diabetes and Endocrine Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Northwestern University The Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachussetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Sisters of Charity Hospital, Buffalo
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77230
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19898989
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.
Results Reference
result

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

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