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

NCT05184231 | Withdrawn

• 1 other identifier: CLIN-52030-454
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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).

Study Arms (2)

Patient cohort

Physician cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: February 13, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

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