Benign Nontoxic and Toxic GoiterPhase 2NCT00145366
rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter
A Phase 2 study testing Recombinant human thyrotropin (Thyrogen) in people with Benign Nontoxic and Toxic Goiter and Graves' Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benign Nontoxic and Toxic Goiter, Graves' Disease
- What is being tested?
- Recombinant human thyrotropin (Thyrogen)
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2002to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with an intact thyroid gland
- Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
- Patients with toxic nodular goiter
- Patients with Graves' disease
Who cannot join
- Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
- Prior 131I treatment
- Alcohol, medicine or drug abuse
- Pregnancy or lactation
- No safe contraception
- Participation in another clinical trial
Show all 12Show fewer
- Allergic reaction towards rhTSH
- Fine needle biopsy without valid diagnostic criteria for benign disease
- Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin
- Incontinence
- Physically or psychic condition that hinders corporation
- Ischemic attack up till 3 months before inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, Funen, 5000
About this study
Official title: Pretreatment With Recombinant Human Thyrotropin (rhTSH) for the Effect on Thyroid Size and Function, and for the Effect of Radioiodine Treatment in Patients With Nodular Goiter. Prospective, Randomized Double-blinded Trials.
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:
- Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
- Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.
- Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
- Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial. As a final note we investigate, in a pilot-study;
- The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.
- Conditions
- Benign Nontoxic and Toxic Goiter, Graves' Disease
- Being tested
- Recombinant human thyrotropin (Thyrogen)
- Keywords
- Benign nontoxic and toxic goiter, rhTSH, 131I, goiter reduction, 131I kinetic, thyroid size, patient satisfaction, adverse effects, BRT, Graves' disease
- Medical subject headings
- Graves Disease, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human thyrotropin (Thyrogen)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Nontoxic and Toxic GoiterStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Viveque Egsgaard Nielsen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145366
- Sponsor's protocol ID
- 008
- Status last verified
- Apr 2009
- First submitted
- 2 Sep 2005
- Last updated
- 28 Dec 2010
- Results posted
- No
Publications
Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Grupe P, Hegedus L. Stimulation with 0.3-mg recombinant human thyrotropin prior to iodine 131 therapy to improve the size reduction of benign nontoxic nodular goiter: a prospective randomized double-blind trial. Arch Intern Med. 2006 Jul 24;166(14):1476-82. doi: 10.1001/archinte.166.14.1476.
PubMed 16864757
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Recombinant Human Thyrotropin (rhTSH) for the Effect on Thyroid Size and Function, and for the Effect of Radioiodine Treatment in Patients With Nodular Goiter. Prospective, Randomized Double-blinded Trials.
- ClinicalTrials.gov ID
- NCT00145366
- Acronym / sponsor ID
- 008
- Conditions
- Benign Nontoxic and Toxic Goiter, Graves' Disease
- Keywords
- Benign nontoxic and toxic goiter, rhTSH, 131I, goiter reduction, 131I kinetic, thyroid size, patient satisfaction, adverse effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Jul 2005 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:
- Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
- Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.
- Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
- Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial. As a final note we investigate, in a pilot-study;
- The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers with an intact thyroid gland
- Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
- Patients with toxic nodular goiter
- Patients with Graves' disease
Key exclusion criteria (12 listed)
- Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
- Prior 131I treatment
- Alcohol, medicine or drug abuse
- Pregnancy or lactation
- No safe contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human thyrotropin (Thyrogen) | Drug | – |
Primary outcome
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Results publication: PubMed 16864757Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Grupe P, Hegedus L. Stimulation with 0.3-mg recombinant human thyrotropin prior to iodine 131 therapy to improve the size reduction of benign nontoxic nodular goiter: a prospective randomized double-blind trial. Arch Intern Med. 2006 Jul 24;166(14):1476-82. doi: 10.1001/archinte.166.14.1476.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viveque Egsgaard Nielsen, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human thyrotropin (Thyrogen) in people with Benign Nontoxic and Toxic Goiter and Graves' Disease, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.