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Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

This study has been completed.
Sponsor:
Information provided by:
Seth Gordhandas Sunderdas Medical College
ClinicalTrials.gov Identifier:
NCT00889525
First received: April 27, 2009
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  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
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:

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 May 23, 2013