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Trial record 1 of 1 for:    NCT01885533
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Post-Radioiodine Graves' Management: The PRAGMA-Study (PRAGMA)

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ClinicalTrials.gov Identifier: NCT01885533
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Cardiff and Vale University Health Board
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information
First Submitted Date February 15, 2013
First Posted Date June 25, 2013
Last Update Posted Date March 30, 2017
Study Start Date March 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2013)
Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK [ Time Frame: 12 months post radio-iodine ]
To compare the incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK:
  • anti-thyroid drugs before and /or after RI
  • anti-thyroid drugs with levothyroxine before and / or after RI
  • watchful monitoring post-RI and introduction of levothyroxine when needed.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2013)
  • Graves orbitopathy [ Time Frame: 12 months post-radiodiodine ]
  • weight gain [ Time Frame: 12 months ]
  • progression of Graves' orbitopathy [ Time Frame: 12 months ]
  • patient satisfaction [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Radioiodine Graves' Management: The PRAGMA-Study
Official Title POST-RADIOIODINE GRAVES' MANAGEMENT
Brief Summary Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients with a history of Graves' disease treated with radioiodine
Condition Graves' Disease
Intervention Not Provided
Study Groups/Cohorts
  • Post-radioiodine medication
    Anti-thyroid drugs
  • Post-radioiodine medications
    anti-thyroid drugs and thyroxine
  • Post-radiodione medication
    watchful monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2017)
803
Original Estimated Enrollment
 (submitted: June 20, 2013)
750
Actual Study Completion Date December 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Out-patients 18 years of age or over, who have given written informed consent to participate in the study
  • Diagnosed with Graves' disease
  • Received radioiodine for treatment of Graves' disease
  • Had a minimum of 12 months follow-up after RI
  • Most recent RI dose 5 years ago or less at the time of enrollment

Exclusion Criteria:

  • Patients unable to give informed consent
  • Age 17 years or younger
  • Cause of thyrotoxicosis other than Graves' disease
  • Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.
  • Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01885533
Other Study ID Numbers 110269
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Newcastle-upon-Tyne Hospitals NHS Trust
Study Sponsor Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
  • Cardiff and Vale University Health Board
  • Royal Devon and Exeter NHS Foundation Trust
Investigators Not Provided
PRS Account Newcastle-upon-Tyne Hospitals NHS Trust
Verification Date March 2017