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Remission Induction and Sustenance in Graves' Disease 2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Laurberg, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT00796913
First received: November 21, 2008
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.


Condition Intervention Phase
Graves Disease
Hyperthyroidism
 Other: Stop medication
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Relapse of hyperthyroidism [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reoccurrence of TSH-receptor autoimmunity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stop of medication after remission Other: Stop medication
Stop medication Stop medication + se supplement
Other Names:
  • stop medication
  • stop medication + se supplement
No Intervention: Medication for 2 yrs after remission
Experimental: Se-yeast 200 Microgr/day + arm A Other: Stop medication
Stop medication Stop medication + se supplement
Other Names:
  • stop medication
  • stop medication + se supplement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

  • Age < 18, severe concomitant disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796913

Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Principal Investigator: Peter Laurberg, MD Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Peter Laurberg, Professor of Endocrinology and Internal medicine, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT00796913     History of Changes
Other Study ID Numbers: RISG2
Study First Received: November 21, 2008
Last Updated: January 22, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
 Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013