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NCT01732406 Clinical Trial

Acromegaly Treatment Quality of Life Study

Acromegaly Clinical Trial

Official title:
Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01732406
Other study ID # 2012P001556
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 19, 2016

Study information
Verified date January 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date December 19, 2016
Est. primary completion date December 19, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Age 18-90

- Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria:

- Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study

- Initiation or discontinuation of testosterone or estrogen within 3 months of entry

- Pregnant and nursing women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acromegaly Quality of Life (ACROQoL) Global Score The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale. Cross-sectional at baseline
Secondary The Gastrointestinal Quality of Life Index (GIQLI) Total Score The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life. Cross-sectional at baseline
Secondary 36-Item Short Form Survey Instrument (SF-36) Physical Health The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions. Cross-sectional at baseline
Secondary 36-Item Short Form Survey (SF-36) Mental Health Summary Score The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions. Cross-sectional at baseline
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