Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel (SALSA)
|Acromegaly||Drug: Somatuline Autogel (lanreotide acetate) Behavioral: Home administration||Phase 3|
|Study Design:||Allocation: Non-Randomized
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|
- 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 ]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').
- Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score. [ Time Frame: 24 weeks ]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 ]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 ]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 ]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 ]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 ]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.
|Study Start Date:||April 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Somatuline Autogel (lanreotide acetate)
Somatuline Autogel (lanreotide acetate) Injection
Drug: Somatuline Autogel (lanreotide acetate)
InjectionsBehavioral: Home administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447499
|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|
|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|
|Study Director:||Sandra L Blethen, M.D. PhD||Ipsen (formerly Tercica)|