Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

NCT ID: NCT00889525

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cushing's Disease Corticotroph Adenoma

Keywords

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Cabergoline

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cabergoline

Group Type EXPERIMENTAL

Cabergoline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seth Gordhandas Sunderdas Medical College

OTHER

Sponsor Role lead

Responsible Party

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Seth Gordhandas Sunderdas Medical College& KEM Hospital

Principal Investigators

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Nalini S Shah, DM

Role: PRINCIPAL_INVESTIGATOR

Seth GSMC and KEM hospital, Mumbai

Locations

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Seth GSMC & KEM hospital

Mumbai, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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EC/104/2005

Identifier Type: -

Identifier Source: org_study_id