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Trial record 3 of 4 for:    anatabine

Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01551498
First received: March 5, 2012
Last updated: October 23, 2014
Last verified: October 2014

March 5, 2012
October 23, 2014
March 2012
January 2013   (final data collection date for primary outcome measure)
Numbers of subjects experiencing adverse effects as a measure of safety [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects
Same as current
Complete list of historical versions of study NCT01551498 on ClinicalTrials.gov Archive Site
Measured changes in markers of autoimmune thyroiditis: changes in blood levels of anti-thyroid auto-antibodies, and changes in the volume and vascularization of the thyroid [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To determine if dietary supplementation with Anatabloc has an effect on antithyroid autoantibody levels, thyroid structure, and/or thyroid function in subjects with autoimmune thyroiditis
Same as current
Not Provided
Not Provided
 
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabloc on Antithyroid Autoantibodies and Thyroid Function in Autoimmune Thyroiditis

This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.

This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Thyroiditis, Autoimmune
  • Dietary Supplement: Anatabloc Supplement
    Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
  • Dietary Supplement: Placebo
    Placebo, as mint flavored lozenges, to be taken 3 times each day
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Anatabloc Supplement
    Intervention: Dietary Supplement: Anatabloc Supplement
Schmeltz LR, Blevins TC, Aronoff SL, Ozer K, Leffert JD, Goldberg MA, Horowitz BS, Bertenshaw RH, Troya P, Cohen AE, Lanier RK, Wright C 4th. Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: a randomized controlled clinical trial. J Clin Endocrinol Metab. 2014 Jan;99(1):E137-42. doi: 10.1210/jc.2013-2951. Epub 2013 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
February 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adults 18-70 years of age
  • having positive antibodies against thyroid peroxidase
  • having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis

Exclusion Criteria:

  • having evidence of end-stage thyroiditis
  • being a current smoker or smokeless tobacco user
  • be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody
  • be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551498
RCP-007
No
Rock Creek Pharmaceuticals, Inc.
Rock Creek Pharmaceuticals, Inc.
Not Provided
Study Director: Maria Varga, MD Star Scientific, Inc
Rock Creek Pharmaceuticals, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP