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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05184231
• Other study ID #: CLIN-52030-454
• Status: Withdrawn
• Start date: February 13, 2023
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction with symptom control of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Patient satisfaction with frequency of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Patient satisfaction with mode of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Patient satisfaction with convenience of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Patient satisfaction with injection site reactions of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Patient satisfaction with adverse reactions to SSA treatment		During the whole study period (approximately 3 months).
Secondary	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).
Secondary	Physician satisfaction with symptom control of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Physician satisfaction with frequency of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Physician satisfaction with mode of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Physician satisfaction with convenience of administration of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Physician satisfaction with injection site reactions of SSA treatment		During the whole study period (approximately 3 months).
Secondary	Physician satisfaction with adverse reactions to SSA treatment		During the whole study period (approximately 3 months).
Secondary	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).
Secondary	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).
Secondary	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).