Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

This study has been completed.

First Received: April 27, 2009 Last Updated: 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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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
Cabergoline: Experimental	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, Maharashtra
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:	Seth Gordhandas Sunderdas Medical College& KEM Hospital ( Dr Nalini S Shah )
Study ID Numbers:	EC/104/2005
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00889525 History of Changes
Health Authority:	India: Drugs Controller General of India

Keywords provided by Seth Gordhandas Sunderdas Medical College:

Cabergoline

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antineoplastic Agents
Physiological Effects of Drugs
Antiparkinson Agents
Central Nervous System Neoplasms
Pituitary Neoplasms
Dopamine Agonists
Brain Diseases
Pituitary ACTH Hypersecretion
Neoplasms by Site
Hyperpituitarism
Hypothalamic Neoplasms
Therapeutic Uses

Nervous System Neoplasms
Endocrine Gland Neoplasms
Hypothalamic Diseases
Neoplasms by Histologic Type
Pituitary Diseases
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases
Supratentorial Neoplasms
Pharmacologic Actions
ACTH-Secreting Pituitary Adenoma
Brain Neoplasms
Neoplasms
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010