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Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889525
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seth Gordhandas Sunderdas Medical College
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 27, 2009
First Posted: April 29, 2009
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by Seth Gordhandas Sunderdas Medical College:
Cabergoline

Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Pituitary Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases
Hyperpituitarism
Cabergoline
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs