Study of Cabergoline in Treatment of Corticotroph Pituita... | NCT00889525

Studies
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

NCT00889525

Sponsor

Seth Gordhandas Sunderdas Medical College

Status

Completed

Last Update Posted

Apr 29, 2009Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Cushing's Disease
Corticotroph Adenoma

Interventions

Cabergoline

Countries

India

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

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

Apr 28, 2009

Last Update Posted Date

Apr 29, 2009Estimated

Description Module

Brief Summary

This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.

Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cabergoline	Experimental		Drug: Cabergoline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabergoline	Drug	Dose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology

Exclusion Criteria:

Patient's intolerance to drug or known sensitivity to ergot derivatives
Pregnancy, lactation or female wishing to be pregnant
Any serious medical illness
Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nalini S Shah, DM	Seth GSMC and KEM hospital, Mumbai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seth GSMC & KEM hospital		Mumbai	Maharashtra	4000012	India

Condition Browse Module

MeSH Terms

ID	Term
D047748	Pituitary ACTH Hypersecretion
D049913	ACTH-Secreting Pituitary Adenoma

Ancestor Terms

ID	Term
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077465	Cabergoline

Ancestor Terms

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided