Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China

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.

Study Overview

• Status: Withdrawn
• Conditions: Acromegaly

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Ipsen Medical Director

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

For Patients:

• Age 18 years or older
• Diagnosed with acromegaly
• Receiving current SSA injections for acromegaly treatment for at least 3 months
• Signed electronic Informed Consent Form (eICF)

For Physicians:

• Licensed endocrinologists or neurosurgeons
• Having prescribed SSAs for at least five patients with acromegaly in the past 6 months
• Signed eICF

Exclusion Criteria:

• Patients will not be included in the survey if they meet any of the following criteria:
• Patients who are not able to successfully complete the questionnaire independently
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient cohort
Physician cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).
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).

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Anticipated): February 13, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: CLIN-52030-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No