Trial Outcomes & Findings for A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome (NCT NCT00569582)
NCT ID: NCT00569582
Last Updated: 2013-08-22
Results Overview
Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2013-08-22
Participant Flow
24 week multicenter, open-label trial after failed multimodality therapy at 14 U.S. academic medical centers and three private research centers.
Adults with endogenous Cushing's Syndrome associated with either type 2 diabetes mellitus/impaired glucose tolerance or a diagnosis of hypertension.
Participant milestones
| Measure |
Mifepristone
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Mifepristone
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Subject was too ill to travel.
|
1
|
|
Overall Study
Subject was non-compliant.
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome
Baseline characteristics by cohort
| Measure |
Mifepristone
n=50 Participants
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
45.4 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Patients with at least 30 days of dosing.
Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
Outcome measures
| Measure |
Mifepristone
n=25 Participants
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Improvement in Diabetes and/or Glucose Intolerance.
|
15 participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.
Outcome measures
| Measure |
Mifepristone
n=21 Participants
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Decrease in Diastolic Blood Pressure.
|
8 participants
|
Adverse Events
Mifepristone
Serious events: 16 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mifepristone
n=50 participants at risk
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Infections and infestations
Legionella pneumonia
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis Erosive
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Intracranial Aneurysm
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • Number of events 2 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
2/50 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
Confusional State
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Investigations
Blood Potassium Decreased
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
General disorders
Asthenia
|
2.0%
1/50 • Number of events 2 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Endocrine disorders
Adrenal Insufficiency
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Infections and infestations
Subcutaneous Abscess
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Cardiac disorders
Angina Pectoris
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adrenal carcinoma
|
4.0%
2/50 • Number of events 2 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm progression
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neuroendocrine carcinoma
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Mifepristone
n=50 participants at risk
Mifepristone was administered at doses of 300-1200 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
48.0%
24/50 • Number of events 40 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
13/50 • Number of events 21 • 24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
18.0%
9/50 • Number of events 12 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
6/50 • Number of events 8 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • Number of events 5 • 24 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
4/50 • Number of events 4 • 24 weeks
|
|
General disorders
Fatigue
|
48.0%
24/50 • Number of events 37 • 24 weeks
|
|
General disorders
Oedema peripheral
|
26.0%
13/50 • Number of events 31 • 24 weeks
|
|
General disorders
Pain
|
14.0%
7/50 • Number of events 9 • 24 weeks
|
|
General disorders
Asthenia
|
6.0%
3/50 • Number of events 5 • 24 weeks
|
|
General disorders
Malaise
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
General disorders
Oedema
|
6.0%
3/50 • Number of events 6 • 24 weeks
|
|
General disorders
Pitting oedema
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
General disorders
Thirst
|
6.0%
3/50 • Number of events 3 • 24 weeks
|
|
Nervous system disorders
Headache
|
44.0%
22/50 • Number of events 40 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
22.0%
11/50 • Number of events 20 • 24 weeks
|
|
Nervous system disorders
Somnolence
|
10.0%
5/50 • Number of events 7 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
15/50 • Number of events 20 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
8/50 • Number of events 9 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
7/50 • Number of events 11 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
6/50 • Number of events 6 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.0%
4/50 • Number of events 6 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.0%
3/50 • Number of events 3 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
Investigations
Blood potassium decreased
|
34.0%
17/50 • Number of events 27 • 24 weeks
|
|
Investigations
Thyroid function test abnormal
|
50.0%
9/18 • Number of events 11 • 24 weeks
|
|
Investigations
Blood triglycerides increased
|
8.0%
4/50 • Number of events 5 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
4/50 • Number of events 5 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.0%
4/50 • Number of events 4 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.0%
3/50 • Number of events 5 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
14.0%
7/50 • Number of events 9 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
6/50 • Number of events 10 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
8.0%
4/50 • Number of events 5 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50 • Number of events 5 • 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
10/20 • Number of events 12 • 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
5/50 • Number of events 6 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypertension
|
24.0%
12/50 • Number of events 14 • 24 weeks
|
|
Metabolism and nutrition disorders
Hot flush
|
6.0%
3/50 • Number of events 3 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
8.0%
4/50 • Number of events 4 • 24 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.0%
3/50 • Number of events 8 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.0%
8/50 • Number of events 11 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
4/50 • Number of events 4 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
5/50 • Number of events 12 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
6.0%
3/50 • Number of events 5 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
3/50 • Number of events 4 • 24 weeks
|
|
Eye disorders
Vision blurred
|
8.0%
4/50 • Number of events 5 • 24 weeks
|
|
Endocrine disorders
Cushing's syndrome
|
8.0%
4/50 • Number of events 6 • 24 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
6.0%
3/50 • Number of events 3 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60