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Study wasn't feasible anymore. It was withdrawn on 13 Jan 2023.
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The purpose of the protocol is to achieve an in-depth understanding of the current satisfaction status of somatostatin analogue (SSA) treatment for acromegaly through patient and physician surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient cohort | |||
| Physician cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall patient satisfaction with SSA treatment. | To be assessed by four levels of satisfaction including very satisfied, satisfied, dissatisfied, and very dissatisfied | During the whole study period (approximately 3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with symptom control of SSA treatment | During the whole study period (approximately 3 months). | |
| Patient satisfaction with frequency of administration of SSA treatment | During the whole study period (approximately 3 months). |
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Inclusion Criteria:
For Patients:
For Physicians:
Exclusion Criteria:
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Primary care clinic
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| Patient satisfaction with mode of administration of SSA treatment | During the whole study period (approximately 3 months). |
| Patient satisfaction with convenience of administration of SSA treatment | During the whole study period (approximately 3 months). |
| Patient satisfaction with injection site reactions of SSA treatment | During the whole study period (approximately 3 months). |
| Patient satisfaction with adverse reactions to SSA treatment | During the whole study period (approximately 3 months). |
| Physician overall satisfaction with SSA treatment. | The satisfaction rate is calculated as the proportion of physicians who reported to be satisfied or very satisfied with the prescribed SSA treatment. | During the whole study period (approximately 3 months). |
| Physician satisfaction with symptom control of SSA treatment | During the whole study period (approximately 3 months). |
| Physician satisfaction with frequency of administration of SSA treatment | During the whole study period (approximately 3 months). |
| Physician satisfaction with mode of administration of SSA treatment | During the whole study period (approximately 3 months). |
| Physician satisfaction with convenience of administration of SSA treatment | During the whole study period (approximately 3 months). |
| Physician satisfaction with injection site reactions of SSA treatment | During the whole study period (approximately 3 months). |
| Physician satisfaction with adverse reactions to SSA treatment | During the whole study period (approximately 3 months). |
| Aspects of patient concern before initiating SSA treatment | The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned. | During the whole study period (approximately 3 months). |
| Aspects of physician concern before prescribing SSA treatment | The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned. | During the whole study period (approximately 3 months). |
| Overall patient satisfaction with SSA treatment: satisfied versus dissatisfied with their SSA treatment. | The patient satisfaction will be categorized as binary variables including satisfied (very satisfied and satisfied) versus dissatisfied (dissatisfied and very dissatisfied). | During the whole study period (approximately 3 months). |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |