Somatuline Autogel Preference and Health Economy Study (SAPHE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT00681187

First received: May 19, 2008

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Results First Received: September 1, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Neuroendocrine Tumour With Carcinoid Symptoms
Intervention:	Drug: lanreotide (Autogel formulation)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Group 1 Self or Partner First Then HCP Administration	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.
Group 2 HCP Then Self or Partner Administration	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.

Description

Group 1 Self or Partner First Then HCP Administration

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.

Group 2 HCP Then Self or Partner Administration

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.

Participant Flow: Overall Study

	Group 1 Self or Partner First Then HCP Administration	Group 2 HCP Then Self or Partner Administration
STARTED	11	15
COMPLETED	10	13
NOT COMPLETED	1	2
Withdrawal by Subject	1	0
Death	0	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Group 1 Self or Partner First Then HCP Administration	Self or partner administration followed by HCP administration.
Group 2 HCP Then Self or Partner Administration	Administration by HCP then self or partner administration.
Total	Total of all reporting groups

Baseline Measures

	Group 1 Self or Partner First Then HCP Administration	Group 2 HCP Then Self or Partner Administration	Total
Number of Participants [units: participants]	11	15	26
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	8	14
>=65 years	5	7	12
Age [units: years] Mean ± Standard Deviation	63.2 ± 6.5	60.0 ± 12.7	61.4 ± 10.5
Gender [units: participants]
Female	4	8	12
Male	7	7	14
Region of Enrollment [units: participants]
Denmark	3	4	7
Norway	1	3	4
Sweden	7	8	15

Outcome Measures

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1. Primary:

Subject Preference for Self or Partner Administration [ Time Frame: Between week 30 to 34 ]

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2. Secondary:

Number of Patients Stating at Least One Injection Interfered With Daily Activities [ Time Frame: Between baseline to week 32, after each injection (8-9 injections) ]

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3. Secondary:

Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing [ Time Frame: Between baseline to week 32, after each injection (8-9 injections) ]

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4. Secondary:

Days Sick Leave [ Time Frame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration) ]

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5. Secondary:

Total Number of Visits to HCP Due to Carcinoid Symptoms [ Time Frame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration) ]

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6. Secondary:

Perceived Symptom Control Evaluation in Respect to Episodes of Flushing [ Time Frame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration). ]

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7. Secondary:

Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea [ Time Frame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration). ]

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8. Secondary:

Chromogranin A Levels [ Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. ]

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9. Secondary:

5-hydroxyindoleacetic Acid (5-HIAA) Levels [ Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. ]

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10. Secondary:

Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method [ Time Frame: Between week 30 to 34 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Director, Endocrinology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00681187 History of Changes
Other Study ID Numbers:	A-99-52030-216
Study First Received:	May 19, 2008
Results First Received:	September 1, 2011
Last Updated:	February 9, 2012
Health Authority:	Sweden: Medical Products Agency Norway: Norwegian Medicines Agency Denmark: Danish Medicines Agency

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