Acromegaly: Patient And Physician Perspectives

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Acromegaly
Related Access Program
Novartis Pharmaceuticals – Acromegaly
Related Clinical Trial
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Brief Title

Acromegaly: Patient And Physician Perspectives

Official Title

Acromegaly: Patient And Physician Perspectives

Brief Summary

      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.

Study Type

Observational

Primary Outcome

Assess patient experiences with acromegaly treatments through patient questionnaires.

Secondary Outcome

 Assess the concordance between patient's and physician's perceptions of acromegaly control (with/without biochemical lab results),

Condition

Acromegaly

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

152

Start Date

July 2, 2018

Completion Date

September 1, 2020

Primary Completion Date

December 1, 2019

Eligibility Criteria

        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®)

Gender

All

Ages

18 Years - 94 Years

Accepts Healthy Volunteers

No

Contacts

Lizheng Shi, PhD, MsPharm, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03613623

Organization ID

2018-879

Responsible Party

Principal Investigator

Study Sponsor

Tulane University

Collaborators

 Chiasma, Inc.

Study Sponsor

Lizheng Shi, PhD, MsPharm, Principal Investigator, Tulane University

Verification Date

October 2020