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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00447499
First received: March 12, 2007
Last updated: June 18, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

Resource links provided by NLM:


Further study details as provided by Ipsen:

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Blood samples taken before and 60 and 120 min after glucose load from fasting patient.

  • Total Symptom Questionnaire Score at Week 24/Termination [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


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)
Arms Assigned Interventions
Experimental: Somatuline Autogel (lanreotide acetate)
Somatuline Autogel (lanreotide acetate) Injection
Drug: Somatuline Autogel (lanreotide acetate)
Injections
Behavioral: Home administration
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
NYU School of Medicine
New York, New York, United States, 10010
Columbia University
New York, New York, United States, 10032
Sisters of Charity Hospital, Buffalo
Williamsville, New York, United States, 14221
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
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77230
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Sandra L Blethen, M.D. PhD Ipsen (formerly Tercica)
  More Information

Publications:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00447499     History of Changes
Other Study ID Numbers: MS315
Study First Received: March 12, 2007
Results First Received: March 23, 2010
Last Updated: June 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ipsen:
Acromegaly
Somatostatin Analogs
Somatuline® Autogel®
lanreotide
growth hormone
IGF-1
Inappropriate Growth Hormone Secretion Syndrome
Somatotropin Hypersecretion Syndrome
Inappropriate GH Secretion Syndrome

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Angiopeptin
Lanreotide
Somatostatin
Antineoplastic Agents
Cardiovascular Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014