NCT00889525

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

First QC Date

April 27, 2009

Last Update Submit

April 28, 2009

Conditions

Cushing's DiseaseCorticotroph Adenoma

Keywords

Cabergoline

Outcome Measures

Primary Outcomes (1)

  • Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl

Study Arms (1)

Cabergoline

EXPERIMENTAL
Drug: Cabergoline

Interventions

CabergolineDRUG

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.

Cabergoline

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seth GSMC & KEM hospital

Mumbai, Maharashtra, 4000012, India

Location

MeSH Terms

Conditions

Pituitary ACTH HypersecretionACTH-Secreting Pituitary Adenoma

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPituitary NeoplasmsEndocrine Gland NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Nalini S Shah, DM

    Seth GSMC and KEM hospital, Mumbai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

November 1, 2007

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

IN(1)