Back to resultsStudy of Cabergoline in Treatment of Corticotroph Pituitary Tumor
Primary Purpose
Cushing's Disease, Corticotroph Adenoma
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Cabergoline
Sponsored by
About this trial
This is an interventional treatment trial for Cushing's Disease focused on measuring Cabergoline
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
Sites / Locations
- Seth GSMC & KEM hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabergoline
Arm Description
Outcomes
Primary Outcome Measures
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT00889525
First Posted
April 27, 2009
Last Updated
April 28, 2009
Sponsor
Seth Gordhandas Sunderdas Medical College
1. Study Identification
Unique Protocol Identification Number
NCT00889525
Brief Title
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
Official Title
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Seth Gordhandas Sunderdas Medical College
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease, Corticotroph Adenoma
Keywords
Cabergoline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Arm Title
Cabergoline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalini S Shah, DM
Organizational Affiliation
Seth GSMC and KEM hospital, Mumbai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seth GSMC & KEM hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
4000012
Country
India
12. IPD Sharing Statement
Learn more about this trial
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
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