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

Sponsor
Ipsen (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05184231
Collaborator
(none)
216
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    216 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patient cohort
    Physician cohort

    Outcome Measures

    Primary Outcome Measures

    1. Overall patient satisfaction with SSA treatment. [During the whole study period (approximately 3 months).]

      To be assessed by four levels of satisfaction including very satisfied, satisfied, dissatisfied, and very dissatisfied

    Secondary Outcome Measures

    1. Patient satisfaction with symptom control of SSA treatment [During the whole study period (approximately 3 months).]

    2. Patient satisfaction with frequency of administration of SSA treatment [During the whole study period (approximately 3 months).]

    3. Patient satisfaction with mode of administration of SSA treatment [During the whole study period (approximately 3 months).]

    4. Patient satisfaction with convenience of administration of SSA treatment [During the whole study period (approximately 3 months).]

    5. Patient satisfaction with injection site reactions of SSA treatment [During the whole study period (approximately 3 months).]

    6. Patient satisfaction with adverse reactions to SSA treatment [During the whole study period (approximately 3 months).]

    7. Physician overall satisfaction with SSA treatment. [During the whole study period (approximately 3 months).]

      The satisfaction rate is calculated as the proportion of physicians who reported to be satisfied or very satisfied with the prescribed SSA treatment.

    8. Physician satisfaction with symptom control of SSA treatment [During the whole study period (approximately 3 months).]

    9. Physician satisfaction with frequency of administration of SSA treatment [During the whole study period (approximately 3 months).]

    10. Physician satisfaction with mode of administration of SSA treatment [During the whole study period (approximately 3 months).]

    11. Physician satisfaction with convenience of administration of SSA treatment [During the whole study period (approximately 3 months).]

    12. Physician satisfaction with injection site reactions of SSA treatment [During the whole study period (approximately 3 months).]

    13. Physician satisfaction with adverse reactions to SSA treatment [During the whole study period (approximately 3 months).]

    14. Aspects of patient concern before initiating SSA treatment [During the whole study period (approximately 3 months).]

      The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned.

    15. Aspects of physician concern before prescribing SSA treatment [During the whole study period (approximately 3 months).]

      The magnitude of concern will be assessed by four levels including not concerned, slightly concerned, concerned, and very concerned.

    16. Overall patient satisfaction with SSA treatment: satisfied versus dissatisfied with their SSA treatment. [During the whole study period (approximately 3 months).]

      The patient satisfaction will be categorized as binary variables including satisfied (very satisfied and satisfied) versus dissatisfied (dissatisfied and very dissatisfied).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ipsen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT05184231
    Other Study ID Numbers:
    • CLIN-52030-454
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acromegaly

    Study Results

    No Results Posted as of Aug 10, 2022