Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

This study has been completed.

First Received on April 27, 2009. Last Updated on April 28, 2009 History of Changes

Sponsor:	Seth Gordhandas Sunderdas Medical College
Information provided by:	Seth Gordhandas Sunderdas Medical College
ClinicalTrials.gov Identifier:	NCT00889525

Purpose

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.

Condition	Intervention	Phase
Cushing's Disease Corticotroph Adenoma	Drug: Cabergoline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cushing's Syndrome Pituitary Tumors

Drug Information available for: Cabergoline Cabergoline diphosphate

U.S. FDA Resources

Further study details as provided by Seth Gordhandas Sunderdas Medical College:

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

Study Start Date:

November 2007

Arms	Assigned Interventions
Experimental: Cabergoline	Drug: Cabergoline 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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889525

Locations

India
Seth GSMC & KEM hospital
Mumbai, Maharashtra, India, 4000012

Sponsors and Collaborators

Seth Gordhandas Sunderdas Medical College

Investigators

Principal Investigator:

Nalini S Shah, DM

Seth GSMC and KEM hospital, Mumbai

More Information

No publications provided

Responsible Party:	Dr Nalini S Shah, Seth Gordhandas Sunderdas Medical College& KEM Hospital
ClinicalTrials.gov Identifier:	NCT00889525 History of Changes
Other Study ID Numbers:	EC/104/2005
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
Health Authority:	India: Drugs Controller General of India

Keywords provided by Seth Gordhandas Sunderdas Medical College:

Cabergoline

Additional relevant MeSH terms:

Adenoma
Cushing Syndrome
Pituitary ACTH Hypersecretion
Pituitary Neoplasms
ACTH-Secreting Pituitary Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Cabergoline
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on February 09, 2012