Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Cushing's Disease Clinical Trial

Official title:

Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889525
• Other study ID #: EC/104/2005
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2009
• Last updated: April 28, 2009
• Start date: November 2007

Study information

• Verified date: April 2009
• Source: Seth Gordhandas Sunderdas Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Corticotroph Adenoma
• Cushing's Disease
• Pituitary ACTH Hypersecretion
• Pituitary Neoplasms

Intervention

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.

Locations

Country	Name	City	State
India	Seth GSMC & KEM hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Seth Gordhandas Sunderdas Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl