Acromegaly: Patient And Physician Perspectives

NCT ID: NCT03613623

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2020-09-01

Brief Summary

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The purpose of the study is to assess the experiences of individuals with acromegaly who are receiving injections as part of their treatment regimen. Another objective of the study is to compare the patients' perception with their doctors' perceptions. The answers are important to help researchers and physicians understand what it is really like to take currently available treatments so that they can make efforts to improve patients' healthcare experiences, reduce treatment burden and, ultimately, improve patient's quality of life.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Patients diagnosed with acromegaly and currently taking long-acting somatostatin analogues for treatment.

No interventions assigned to this group

Physicians

Physicians for those treating the patients enrolled in the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years-old and \<95 years-old
* Patient self-reported acromegaly diagnosis which will be further confirmed by a knowledge screening based on current medications and doses
* Currently on injectable Somatostatin analogues (SSA), Sandostatin® LAR or Somatuline® Depot, for \>=12 months
* Have not had a change in dosage of their acromegaly treatment at the time of or since their last office visit
* Have seen their treating acromegaly physician within the past 12 +/-2 months NOTE: This timeframe allows two additional months for scheduling an appointment with their physician, since most patients should see their acromegaly physician at least once every 12 months
* Ability to read and understand English
* Live and receive acromegaly treatments in the US
* Willing to provide signed informed consent

Exclusion Criteria

* Previous or current participant in Mycapssa® (octreotide capsules) trial
* Use of Pegvisomant (Somavert®) monotherapy
* Use of Pasireotide (Signifor®)
Minimum Eligible Age

18 Years

Maximum Eligible Age

94 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiasma, Inc.

INDUSTRY

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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Lizheng Shi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lizheng Shi, PhD, MsPharm

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

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Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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2018-879

Identifier Type: -

Identifier Source: org_study_id