A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease.

Conditions: Cushing's disease (which is caused by an ACTH producing pituitary adenoma)
MedDRA version: 14.0Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-003264-77-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Biochemically confirmed ACTH dependent Cushing's syndrome originating from a pituitary adenoma (either de novo, recurrent or residual)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Impaired liver function
Renal insufficiency
Symptomatic cholelithiasis
History of pituitary irradiation
Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. <br>;Secondary Objective: Secundary endpoints address the effects of this therapy on bone metabolism, quality of life and coagulation and fibrinolysis. <br>Moreover, in patients that do not normalize under ketoconazole monotherapy, we wish to examine the effectiveness of ketoconazole/cabergoline combination therapy.;Primary end point(s): Urinary free cortisol<br>Midnight salivary cortisol;Timepoint(s) of evaluation of this end point: Monthly from baseline until the end of the study period (9 months)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Cortisol diurnal rhythm measured in saliva and serum<br>2. Quality of life<br>3. Parameters of coagulation and fibrinolysis<br>4. Bone density and serummarkers for bone turnover;Timepoint(s) of evaluation of this end point: 1. Baseline; 3 months; 6 months; 9 months<br>2. Baseline and 9 months<br>3. Baseline and 9 months<br>4. Baseline and 9 months<br>