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Trial record 3 of 6 for:
anatabine
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention) (ASAP)
This study has been completed.
Sponsor:
Rock Creek Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01551498
First received: March 5, 2012
Last updated: October 29, 2015
Last verified: October 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Thyroiditis, Autoimmune | Dietary Supplement: Anatabloc Supplement Dietary Supplement: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Rock Creek Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Numbers of subjects experiencing adverse effects as a measure of safety [ Time Frame: 3 months ]Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects
Secondary Outcome Measures:
- 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 ]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
| Enrollment: | 165 |
| Study Start Date: | March 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
subject takes one oral placebo lozenge, three times per day
|
Dietary Supplement: Placebo
Placebo, as mint flavored lozenges, to be taken 3 times each day
|
|
Active Comparator: Anatabloc Supplement
subject takes one oral Supplement lozenge, three time per day
|
Dietary Supplement: Anatabloc Supplement
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
|
Detailed Description:
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551498
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551498
Locations
| United States, Florida | |
| Metabolic Research Institute, Inc. | |
| West Palm Beach, Florida, United States, 33401 | |
| Florida Medical Clinic, P.A. | |
| Zephyrhills, Florida, United States, 33542 | |
| United States, Illinois | |
| Robert J. Becker, M.D., LTD | |
| La Grange, Illinois, United States, 60561 | |
| United States, Michigan | |
| Associated Endocrinologists, P.C. | |
| West Bloomfield, Michigan, United States, 48322 | |
| United States, New Jersey | |
| New Jersey Physicians, LLC | |
| Clifton, New Jersey, United States, 07012 | |
| United States, Texas | |
| Texas Diabetes & Endocrinology | |
| Austin, Texas, United States, 78731 | |
| North Texas Endocrine Center | |
| Dallas, Texas, United States, 75231 | |
| Research Institute of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Texas Diabetes & Endocrinology | |
| Round Rock, Texas, United States, 78681 | |
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Investigators
| Study Director: | Maria Varga, MD | Star Scientific, Inc |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rock Creek Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01551498 History of Changes |
| Other Study ID Numbers: |
RCP-007 |
| Study First Received: | March 5, 2012 |
| Last Updated: | October 29, 2015 |
Keywords provided by Rock Creek Pharmaceuticals, Inc.:
|
Hashimoto Disease Thyroiditis |
Additional relevant MeSH terms:
|
Thyroiditis Thyroiditis, Autoimmune Thyroid Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 22, 2017