AcromegalyNCT05184231
Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China
An observational study of Acromegaly, run by Ipsen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2023to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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:
Show all 9Show fewer
- Licensed endocrinologists or neurosurgeons
- Having prescribed SSAs for at least five patients with acromegaly in the past 6 months
- Signed eICF
Who cannot join
- 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
About this study
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
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Not described | |
| Physician cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction with SSA treatment.
To be assessed by four levels of satisfaction including very satisfied, satisfied, dissatisfied, and very dissatisfied
Measured: During the whole study period (approximately 3 months).
Secondary outcomes (16)
Patient satisfaction with symptom control of SSA treatment
Measured: During the whole study period (approximately 3 months).
Patient satisfaction with frequency of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Patient satisfaction with mode of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Patient satisfaction with convenience of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Patient satisfaction with injection site reactions of SSA treatment
Measured: During the whole study period (approximately 3 months).
Patient satisfaction with adverse reactions to SSA treatment
Measured: 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.
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with symptom control of SSA treatment
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with frequency of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with mode of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with convenience of administration of SSA treatment
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with injection site reactions of SSA treatment
Measured: During the whole study period (approximately 3 months).
Physician satisfaction with adverse reactions to SSA treatment
Measured: 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.
Measured: 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.
Measured: 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).
Measured: During the whole study period (approximately 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start13 Feb 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Study wasn't feasible anymore. It was withdrawn on 13 Jan 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184231
- Sponsor's protocol ID
- CLIN-52030-454
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China
- ClinicalTrials.gov ID
- NCT05184231
- Acronym / sponsor ID
- CLIN-52030-454
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study wasn't feasible anymore. It was withdrawn on 13 Jan 2023.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | – |
| Physician cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (9 listed)
- 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)
- Licensed endocrinologists or neurosurgeons
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall patient satisfaction with SSA treatment.
Time frame: During the whole study period (approximately 3 months).
To be assessed by four levels of satisfaction including very satisfied, satisfied, dissatisfied, and very dissatisfied
16 secondary outcomes
Patient satisfaction with symptom control of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Patient satisfaction with frequency of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Patient satisfaction with mode of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Patient satisfaction with convenience of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Patient satisfaction with injection site reactions of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Patient satisfaction with adverse reactions to SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician overall satisfaction with SSA treatment.
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with symptom control of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with frequency of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with mode of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with convenience of administration of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with injection site reactions of SSA treatment
Time frame: During the whole study period (approximately 3 months).
Physician satisfaction with adverse reactions to SSA treatment
Time frame: During the whole study period (approximately 3 months).
Aspects of patient concern before initiating SSA treatment
Time frame: During the whole study period (approximately 3 months).
Aspects of physician concern before prescribing SSA treatment
Time frame: During the whole study period (approximately 3 months).
Overall patient satisfaction with SSA treatment: satisfied versus dissatisfied with their SSA treatment.
Time frame: During the whole study period (approximately 3 months).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient satisfaction with SSA treatment. (time frame: During the whole study period (approximately 3 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.