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

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00447499
• Collaborator: (none)
• Enrollment: 59
• Locations: 13
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: Somatuline Autogel (lanreotide acetate); Behavioral: Home administration	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Somatuline Autogel (lanreotide acetate) Somatuline Autogel (lanreotide acetate) Injection	Drug: Somatuline Autogel (lanreotide acetate); Injections; Behavioral: Home administration; Questionnaire

Outcome Measures

Primary Outcome Measures

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. [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').

Secondary Outcome Measures

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

2. Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study [24 weeks]

   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. [24 Weeks]

   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 [24 Weeks]

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

5. Total Symptom Questionnaire Score at Week 24/Termination [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.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Diabetes and Endocrine Associates	La Mesa	California	United States	91942
2	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
3	Denver VA Medical Center	Denver	Colorado	United States	80220
4	Northwestern University The Feinberg School of Medicine	Chicago	Illinois	United States	60611
5	Johns Hopkins University	Baltimore	Maryland	United States	21287
6	Massachussetts General Hospital	Boston	Massachusetts	United States	02114
7	NYU School of Medicine	New York	New York	United States	10010
8	Columbia University	New York	New York	United States	10032
9	Sisters of Charity Hospital, Buffalo	Williamsville	New York	United States	14221
10	Oregon Health and Science University	Portland	Oregon	United States	97239
11	Research Institute of Dallas	Dallas	Texas	United States	75231
12	Baylor College of Medicine	Houston	Texas	United States	77030
13	University of Texas M.D. Anderson Cancer Center	Houston	Texas	United States	77230

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen (formerly Tercica)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT00447499
• Other Study ID Numbers: MS315
• First Posted: Mar 14, 2007
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• 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; Lanreotide

Study Results

Participant Flow

Recruitment Details	First patient enrolled on 6/28/2007 and last patient completed on 12/11/2008. The study enrolled patients with a diagnosis of acromegaly due to a pituitary tumor. patients were recruited from the patient populations of participating investigators and from referrals from other clinics and private practices. A competitive recruitment was used.
Pre-assignment Detail	Patient had been treated with a long-acting somatostatin analog for at least 3 months prior to Screening, must have had IGF-1 levels < 10% above the upper limit of normal range, OR the patient was somatostatin analog-naïve (if the patient was treated with a dopamine agonist, he/she must have been on the dose for >= 3 months prior to Screening)

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Period Title: Overall Study
STARTED	59
COMPLETED	52
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Overall Participants	59
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.1 (11.9)
Sex: Female, Male (Count of Participants)
Female	30 50.8%
Male	29 49.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 16.9%
Not Hispanic or Latino	49 83.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.7%
Native Hawaiian or Other Pacific Islander	1 1.7%
Black or African American	4 6.8%
White	47 79.7%
More than one race	0 0%
Unknown or Not Reported	6 10.2%
Region of Enrollment (participants) [Number]
United States	59 100%
Dopamine Agonist Treatment (Number) [Number]
Yes	11 18.6%
No	33 55.9%
Missing	15 25.4%
Previous Pituitary Surgery (participants) [Number]
Yes	52 88.1%
No	7 11.9%
Prior Somatostatin Analogue Treatment (participants) [Number]
Yes	38 64.4%
No	6 10.2%
Missing	15 25.4%
Duration of Acromegaly (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	7.8 (6.7)
Time Since Last Pituitary Surgery (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	6.7 (6.2)
Time Since Last Somatostatin Analogue Treatment (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	78.8 (173.3)
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	93.0 (23.8)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Measure Participants	54
Number [Percentage of Participants]	98 166.1%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients switched directly from octreotide.

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate)/Switch Patient
Arm/Group Description
Measure Participants	32
Number [Percent of Participants]	91 154.2%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients switched directly from octreotide who had IGF-1 level measured at the end of study.

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate)/Switch Patient
Arm/Group Description
Measure Participants	32
Number [Percent of Participants]	94 159.3%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients switched directly from octreotide who had GH level measured at the end of study.

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate)
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
Measure Participants	26
Number [Percent of Participants]	89 150.8%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients switched directly from octreotide who had GH level measured at the end of study.

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Measure Participants	26
Mean (Standard Deviation) [ng/mL]	-0.3 (1.3)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Measure Participants	59
Mean (Standard Deviation) [On a Scale from -10 to 10]	0.9 (3.6)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.

Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Measure Participants	56
Mean (Standard Deviation) [On a Scale from -6 to 6]	4.6 (1.8)

Adverse Events

Time Frame	Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Arm/Group Title	Somatuline Autogel (Lanreotide Acetate) Injection
Arm/Group Description	Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
All Cause Mortality
	Somatuline Autogel (Lanreotide Acetate) Injection
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Somatuline Autogel (Lanreotide Acetate) Injection
	Affected / at Risk (%)	# Events
Total	5/59 (8.5%)
Gastrointestinal disorders
Abdominal pain	1/59 (1.7%)	1
Pancreatitis	1/59 (1.7%)	1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/59 (1.7%)	1
Obesity	1/59 (1.7%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/59 (1.7%)	1
Back pain	1/59 (1.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	1/59 (1.7%)	1
Thyroid gland Cancer	1/59 (1.7%)	1
Other (Not Including Serious) Adverse Events
	Somatuline Autogel (Lanreotide Acetate) Injection
	Affected / at Risk (%)	# Events
Total	52/59 (88.1%)
Gastrointestinal disorders
Abdominal Pain	9/59 (15.3%)	17
Abdominal Pain Upper	9/59 (15.3%)	11
Constipation	3/59 (5.1%)	5
Diarrhoea	28/59 (47.5%)	68
Flatulence	5/59 (8.5%)	6
Nausea	10/59 (16.9%)	13
Stomach Discomfort	3/59 (5.1%)	6
Injection Site Irritation	5/59 (8.5%)	5
General disorders
Asthenia	3/59 (5.1%)	3
Fatigue	7/59 (11.9%)	14
Injection Site Mass	4/59 (6.8%)	6
Injection Site Nodule	3/59 (5.1%)	9
Injection Site Pain	12/59 (20.3%)	18
Injection Site Pruritus	5/59 (8.5%)	5
Injection Site Swelling	5/59 (8.5%)	7
Infections and infestations
Influenza	3/59 (5.1%)	3
Nasopharyngitis	3/59 (5.1%)	3
Musculoskeletal and connective tissue disorders
Arthralgia	9/59 (15.3%)	15
Back Pain	8/59 (13.6%)	12
Muscle Spasms	4/59 (6.8%)	6
Myalgia	3/59 (5.1%)	4
Pain In Extremity	4/59 (6.8%)	12
Nervous system disorders
Dizziness	4/59 (6.8%)	4
Headache	16/59 (27.1%)	37
Paraesthesia	4/59 (6.8%)	4
Psychiatric disorders
Insomnia	3/59 (5.1%)	5
Respiratory, thoracic and mediastinal disorders
Cough	3/59 (5.1%)	3
Skin and subcutaneous tissue disorders
Alopecia	4/59 (6.8%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.