Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Sponsor

Seth Gordhandas Sunderdas Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT00889525

Collaborator

(none)

Location

Arm

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cushing's Disease Corticotroph Adenoma	Drug: Cabergoline	Phase 3

Study Design

Study Type:

Interventional

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

Study Start Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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