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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02297945
Other study ID # HRA112025-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2015
Est. completion date April 29, 2020

Study information

Verified date September 2020
Source HRA Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this prospective, international phase III/IV study is to assess the efficacy and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.


Description:

This study will include Cushing disease patients with persistent or recurrent disease (after pituitary surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to defer surgery. It will also include patients with ectopic ACTH syndrome (either occult, after surgery failure, or inoperable or metastatic) and patients with Cushing's syndrome from adrenal causes.

The ability of metyrapone to normalize urinary free cortisol levels will be assessed during up to 36 weeks (9 months) of treatment. Patients participating in this study and who are controlled or close to the target at the end of a 3-months period may continue with an optional extension period of 6 months in which the long-term efficacy and safety profiles of metyrapone will be assessed. This extension study is intended to provide new findings to consolidate existing efficacy and safety data on metyrapone in the treatment of Cushing's syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 29, 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with endogenous Cushing's syndrome:

- Cushing disease patients with persistent or recurrent disease (after pituitary surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to defer surgery;

- Patients with ectopic ACTH syndrome (either occult, after surgery failure, or inoperable or metastatic);

- Patients with Cushing's syndrome from adrenal causes

Exclusion Criteria:

1. Pseudo Cushing's syndrome

2. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least three 24-hour urinary sampling measurements over the previous 2 months

3. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small cell lung carcinoma

4. Life expectancy less than 3 months

5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting ectopic tumor or bilateral adrenalectomy planned before the week 12 visit

6. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)

7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI for patients with Cushing's disease

8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy (for otherwise eligible patients, blood pressure medication may be adjusted to meet this criterion)

9. Severe hypokalemia (< 2.5 mmol/L) despite corrective measures

10. White blood cell counts <3 x 109 /L; hemoglobin <10 g/dL; platelets <100 x 109 /L

11. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that in the judgment of the investigator, would present excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
metyrapone
Single arm study

Locations

Country Name City State
Belgium University hospital Antwerp Antwerp
Belgium CHU Erasme Brussels
Belgium University hospital Saint Luc Brussels
Belgium CHU Liège Liege
Germany Charité Berlin Berlin
Germany Universitätsklinikum Essen Essen
Germany Munich university Munich
Germany University hospital Wuerzburg Wuerzburg
Hungary Semmelweis Egyetem II. Belgyógyászati Klinika Budapest
Hungary State health center Budapest
Hungary University Debrecen Debrecen
Hungary University of Pecs Pecs
Hungary University of Szeged Szeged
Italy Grande Ospedale Metropolitano Niguarda Milan
Italy Ospedale San Luca IRCCS Istituto Auxologico Italiano Milan
Italy S. Giuseppe Hospital Milan
Italy Federico II University Naples
Italy San Luigi Gonzaga Hospital, University of Turin Orbassano Turin
Italy University of Padova Padova
Italy University of Turin Turin
Poland Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice
Poland University Hospital Krakow
Poland University Clinical Hospital Wroclaw
Romania Institutul National de Endocrinologie 'C.I Parhon' - Endocrinologie II Bucharest
Romania Institutul National de Endocrinologie 'C.I Parhon' - Endocrinologie VI Bucharest
Romania Spitalul Universitar de Urgenta Militar Central 'Dr Carol Davila' Bucharest
Romania Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca
Romania S.C Centrul Clinic Mediquest SRL Sângeorgiu De Mures
Romania Spitalul Clinic Judetean de Urgenta Sibiu Sibiu
Romania Spitalul Clinic Judetean Mures Târgu-Mures
Spain University hospital clinic of Barcelona Barcelona
Spain Hospital Universitario La Ribera Valencia
Turkey Ankara Numune Training and Research Hospital Ankara
Turkey Dokuz Eylul UMF Izmir
Turkey Ondokuz Mayis University Medical Faculty Samsun
Turkey Karadeniz Teknik University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
HRA Pharma

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Italy,  Poland,  Romania,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Normalization of cortisol levels (urinary free cortisol) 3 months
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