A Study to Confirm Recurrent or Persistent Cushing's Synd... | NCT00796783

Studies
A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia

NCT00796783

Sponsor

Corcept Therapeutics

Status

Terminated

Last Update Posted

Jun 20, 2014Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Cushing's Syndrome

Interventions

Cushing's syndrome confirmation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Not provided

First Submitted Date

Nov 20, 2008

First Submission Date that Met QC Criteria

Nov 20, 2008

First Posted Date

Nov 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2014

Last Update Posted Date

Jun 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Cushing's syndrome confirmation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cushing's syndrome confirmation	Drug		1	Provide access to standard test procedures.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		up to 16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Coleman Gross, MD	Corcept Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
AMCR Institute Inc.		Escondido	California	92026	United States
The Center for Diabetes and Endocrine Care

Condition Browse Module

MeSH Terms

ID	Term
D003480	Cushing Syndrome
D047748	Pituitary ACTH Hypersecretion
D010900	Pituitary Diseases
D002828	Choristoma
D000182	ACTH Syndrome, Ectopic
D000306	Adrenal Cortex Neoplasms
D006628	Hirsutism

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D006964	Hyperpituitarism

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