Trial Outcomes & Findings for Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease) (NCT NCT00612066)
NCT ID: NCT00612066
Last Updated: 2020-08-06
Results Overview
Definition of Treatment Response * The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression. * Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression).
TERMINATED
PHASE2
2 participants
7 weeks
2020-08-06
Participant Flow
Recruitment period May 2006-May 2009
Participant milestones
| Measure |
Rosiglitazone
Rosiglitazone maleate :
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Rosiglitazone
Rosiglitazone maleate :
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)
Baseline characteristics by cohort
| Measure |
Rosiglitazone
n=2 Participants
Rosiglitazone maleate :
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Sample size was too small to do a valid analysis.
Definition of Treatment Response * The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression. * Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression).
Outcome measures
| Measure |
Rosiglitazone
n=1 Participants
Rosiglitazone maleate :
|
|---|---|
|
Number of Responders
|
1 participants
|
Adverse Events
Rosiglitazone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rosiglitazone
n=2 participants at risk
Rosiglitazone maleate :
|
|---|---|
|
General disorders
edema in limbs
|
50.0%
1/2 • Number of events 1
|
Additional Information
Anthony Heaney, M.D. Ph.D
University of California, Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place