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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SALSA

Overview

Status
Completed
Phase
Phase 3
Enrollment
59 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Apr 2007
Primary completion
Dec 2008
Completion
Dec 2008
First posted
14 Mar 2007 (estimated)
Last update posted
20 Nov 2020
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 3

    SALSA

    NCT00447499

    Apr 2007 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

Interventions

  • Somatuline Autogel (lanreotide acetate)Drug
  • Home administrationBehavioral

Arms1

  • Experimental

    Somatuline Autogel (lanreotide acetate)

    Somatuline Autogel (lanreotide acetate) Injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry 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').

Secondary outcomes(6)
  1. Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.

    Time frame · 24 weeks

    Registry 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.

  2. 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

    Registry description

    Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.

  3. 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

    Registry description

    Blood samples taken before and 60 and 120 min after glucose load from fasting patient.

  4. Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients

    Time frame · 24 Weeks

    Registry description

    Blood samples taken before and 60 and 120 min after glucose load from fasting patient.

  5. Total Symptom Questionnaire Score at Week 24/Termination

    Time frame · 24 Weeks

    Registry 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.

  6. Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination

    Time frame · 24 weeks

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 weeks

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.

GroupValue (Percentage of Participants)
Somatuline Autogel (Lanreotide Acetate) Injection98
Secondary and other outcome results(6)
Secondary outcomeNumber· 24 weeks

Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.

GroupValue (Percent of Participants)
Somatuline Autogel (Lanreotide Acetate)/Switch Patient91
Secondary outcomeNumber· 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

GroupValue (Percent of Participants)
Somatuline Autogel (Lanreotide Acetate)/Switch Patient94
Secondary outcomeNumber· 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.

GroupValue (Percent of Participants)
Somatuline Autogel (Lanreotide Acetate)89
Secondary outcomeMean· 24 Weeks

Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients

GroupValue (ng/mL)Spread
Somatuline Autogel (Lanreotide Acetate) Injection-0.31.3
Secondary outcomeMean· 24 Weeks

Total Symptom Questionnaire Score at Week 24/Termination

GroupValue (On a Scale from -10 to 10)Spread
Somatuline Autogel (Lanreotide Acetate) Injection0.93.6
Secondary outcomeMean· 24 weeks

Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination

GroupValue (On a Scale from -6 to 6)Spread
Somatuline Autogel (Lanreotide Acetate) Injection4.61.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Somatuline Autogel (Lanreotide Acetate) InjectionSomatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days–5 / 5952 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2010

Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naïve patients with acromegaly.

Salvatori et al. 2010Pituitarycited by 47

PMID 19898989PMC2855862DOI 10.1007/s11102-009-0207-xPUB-19898989

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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