Somatuline Autogel Preference and Health Economy Study (SAPHE)
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ClinicalTrials.gov Identifier: NCT00681187 |
Recruitment Status :
Completed
First Posted : May 21, 2008
Results First Posted : March 13, 2012
Last Update Posted : November 22, 2019
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Neuroendocrine Tumour With Carcinoid Symptoms |
Intervention |
Drug: lanreotide (Autogel formulation) |
Enrollment | 26 |
Participant Flow
Recruitment Details | Data from ninety-four subjects was reviewed in hospital clinics in Denmark, Norway and Sweden. Of which 32 were ineligible, 36 were eligible but chose not to participate due to lack of motivation, satisfaction with current form of administration or fear of self-injection and 26 were included. Patients were recruited from Jun-08 to Jan-10. |
Pre-assignment Details |
Arm/Group Title | Group 1 Self or Partner First Then HCP Administration | Group 2 HCP Then Self or Partner Administration |
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Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject's home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day. | Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject's home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection. |
Period Title: Overall Study | ||
Started | 11 | 15 |
Completed | 10 | 13 |
Not Completed | 1 | 2 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
Death | 0 | 1 |
Adverse Event | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Group 1 Self or Partner First Then HCP Administration | Group 2 HCP Then Self or Partner Administration | Total | |
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Self or partner administration followed by HCP administration. | Administration by HCP then self or partner administration. | Total of all reporting groups | |
Overall Number of Baseline Participants | 11 | 15 | 26 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 15 participants | 26 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
6 54.5%
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8 53.3%
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14 53.8%
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>=65 years |
5 45.5%
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7 46.7%
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12 46.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 11 participants | 15 participants | 26 participants | |
63.2 (6.5) | 60.0 (12.7) | 61.4 (10.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 15 participants | 26 participants | |
Female |
4 36.4%
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8 53.3%
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12 46.2%
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Male |
7 63.6%
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7 46.7%
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14 53.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 11 participants | 15 participants | 26 participants |
Denmark | 3 | 4 | 7 | |
Norway | 1 | 3 | 4 | |
Sweden | 7 | 8 | 15 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Medical Director, Endocrinology |
Organization: | Ipsen |
Phone: | clinical.trials@ipsen.com |
EMail: | clinical.trials@ipsen.com |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00681187 |
Other Study ID Numbers: |
A-99-52030-216 2007-006514-42 ( EudraCT Number ) |
First Submitted: | May 19, 2008 |
First Posted: | May 21, 2008 |
Results First Submitted: | September 1, 2011 |
Results First Posted: | March 13, 2012 |
Last Update Posted: | November 22, 2019 |