Cushing's SyndromeNCT00796783
A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia
An observational study of Cushing's Syndrome, run by Corcept Therapeutics at 3 sites in United States.
Trial summary
This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Syndrome
- What is being tested?
- Cushing's syndrome confirmation
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2009to Jun 2010
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require adjuvant medical treatment for recurrent or persistent Cushing's syndrome.
Who may be able to join
- Are at least 18 years of age.
- Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
- Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
- Have clinical symptoms and signs of hypercortisolism.
- Are able to provide written informed consent.
- Are expected to complete the study.
Who cannot join
- Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
- Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
- Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
- Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
- Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Have renal failure as defined by a serum creatinine of 202 mg/dL.
- Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AMCR Institute Inc.
Escondido, California, 92026
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
Diabetes and Glandular Disease Research
San Antonio, Texas, 78229
About this study
Official title: A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease
This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
- Conditions
- Cushing's Syndrome
- Being tested
- Cushing's syndrome confirmation
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma, Adrenal carcinoma, Adrenal autonomy, Cortisol, Hypercortisolemia, Cushinoid, Moon facies, Dorsalcervical fat, Plethora, Hirsutism, Violaceous striae, Hormone, Contraceptive
- Medical subject headings
- Cushing Syndrome, Pituitary ACTH Hypersecretion, Pituitary Diseases, Choristoma, ACTH Syndrome, Ectopic, Adrenal Cortex Neoplasms, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cushing's syndrome confirmationDrug
Also called Provide access to standard test procedures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome. Receives: Drug: Cushing's syndrome confirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Coleman Gross, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796783
- Sponsor's protocol ID
- C-1073-410
- Status last verified
- Jun 2014
- First submitted
- 20 Nov 2008
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease
- ClinicalTrials.gov ID
- NCT00796783
- Acronym / sponsor ID
- C-1073-410
- Conditions
- Cushing's Syndrome
- Keywords
- Cushing's Disease, Cushing's Syndrome, Cushings, Pituitary, ACTH, Adrenocorticotropic hormone, Ectopic, Adrenal adenoma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 24 Nov 2008 (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.
This is an observational study to confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Cushing's syndrome confirmationPatients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require medical treatment for recurrent or persistent Cushing's syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with presumed Cushing's disease who have failed pituitary surgery and/or radiation and require adjuvant medical treatment for recurrent or persistent Cushing's syndrome.
Key inclusion criteria (6 listed)
- Are at least 18 years of age.
- Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH secreting pituitary tumor).
- Have previously had pituitary surgery and/or pituitary radiation with the intent of curing or treating Cushing's disease.
- Have clinical symptoms and signs of hypercortisolism.
- Are able to provide written informed consent.
Key exclusion criteria (8 listed)
- Are surgical candidates for pituitary surgery or have had pituitary surgery within 8 weeks before screening.
- Have taken any medication that may interfere with protocol testing procedures within 30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine, primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz, neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral contraceptives).
- Have received investigational treatment (drug, biologic agent or device) within 30 days of screening.
- Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or therapeutic use of ACTH.
- Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such as those with severe obesity, major depression or a history of alcoholism.
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 |
|---|---|---|
| Cushing's syndrome confirmationAlso: Provide access to standard test procedures. | Drug | 1 |
Primary outcome
To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia.
Time frame: up to 16 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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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.
Coleman Gross, MD study director
Corcept Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing's Syndrome, run by Corcept Therapeutics at 3 sites in United States.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To confirm the presence of recurrent or persistent endogenous Cushing's syndrome in patients who have had primary surgical and/or radiation therapy for Cushing's disease and continue to manifest symptoms and signs of hypercortisolemia. (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2014.