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Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

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ClinicalTrials.gov Identifier: NCT00422201
Recruitment Status : Terminated
First Posted : January 15, 2007
Results First Posted : October 14, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cushing's Syndrome
Intervention: Drug: Mifepristone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
18 patients recruited. Recruitment terminated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Arm Mifepristone

Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.

This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.


Participant Flow:   Overall Study
    Single Arm Mifepristone
STARTED   18 
COMPLETED   7 
NOT COMPLETED   11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mifepristone

Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.

This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.


Baseline Measures
   Mifepristone 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.9  (12.48) 
Gender 
[Units: Participants]
 
Female   10 
Male   8 
Region of Enrollment 
[Units: Participants]
 
France   2 
United States   7 
Netherlands   6 
Germany   1 
Italy   2 


  Outcome Measures

1.  Primary:   Glycemic Disorders Improved or Normalized   [ Time Frame: 8 weeks at steady dose ]

2.  Secondary:   Features of Cushing's Syndrome   [ Time Frame: 8 weeks at steady dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As a consequence of the premature study end, analyses performed were primarily descriptive due to the reduced number of enrolled and completed patients.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: HRA Pharma
phone: 0033140331130
e-mail: s.durand@hra-pharma.com


Publications:

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT00422201     History of Changes
Other Study ID Numbers: 070008
07-CH-0008
First Submitted: January 12, 2007
First Posted: January 15, 2007
Results First Submitted: August 8, 2013
Results First Posted: October 14, 2013
Last Update Posted: November 11, 2013