AcromegalyPhase 3SALSANCT00447499
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
A Phase 3 study testing Somatuline Autogel (lanreotide acetate) and Home administration in people with Acromegaly, run by Ipsen at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Somatuline Autogel (lanreotide acetate) and Home administration
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachussetts General Hospital
Boston, Massachusetts, 02114
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, 60611
Research Institute of Dallas
Dallas, Texas, 75231
Denver VA Medical Center
Denver, Colorado, 80220
Baylor College of Medicine
Houston, Texas, 77030
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77230
Diabetes and Endocrine Associates
La Mesa, California, 91942
Cedars Sinai Medical Center
Los Angeles, California, 90048
NYU School of Medicine
New York, New York, 10010
Columbia University
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
Sisters of Charity Hospital, Buffalo
Williamsville, New York, 14221
About this study
Official title: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- Somatuline Autogel (lanreotide acetate), Home administration
- Keywords
- Acromegaly, Somatostatin Analogs, Somatuline® Autogel®, lanreotide, growth hormone, IGF-1, Inappropriate Growth Hormone Secretion Syndrome, Somatotropin Hypersecretion Syndrome, Inappropriate GH Secretion Syndrome
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatuline Autogel (lanreotide acetate)Drug
Injections
Home administrationBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Somatuline Autogel (lanreotide acetate) | Experimental | Somatuline Autogel (lanreotide acetate) Injection Receives: Drug: Somatuline Autogel (lanreotide acetate); Behavioral: Home administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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.
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.
Measured: 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
Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.
Measured: 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.
Blood samples taken before and 60 and 120 min after glucose load from fasting patient.
Measured: 24 Weeks
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.
Measured: 24 Weeks
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.
Measured: 24 Weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen (formerly Tercica)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447499
- Sponsor's protocol ID
- MS315
- Acronym
- SALSA
- Status last verified
- Nov 2020
- First submitted
- 12 Mar 2007
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 19898989