A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing*s disease.

A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing*s disease. - Ketoconazole/octreotide therapy for Cushing's disease.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36055

Enrollment

Registered

2011-09-05

Start date

2011-12-14

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing's disease

Interventions

Ketoconazole treatment (4 times daily 200 mg, maximum 4 times 300 mg during 1 to maximally 5 months) Octreotide treatment (1 injection every 4 weeks: 20 - 30 mg during 6 to maximally 8 months) Caber

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Biochemically confirmed ACTH dependent Cushing's syndrome originating from a pituitary adenoma (either de novo, recurrent or residual)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Urinary free cortisol Midnight salivary cortisol	—

Secondary

Measure	Time frame
Cortisol diurnal rhythm measured in saliva and serum Quality of life Parameters of coagulation and fibrinolysis Bone density and serummarkers for bone turnover	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)