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Trial record 3 of 6 for:    Xerecept

An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

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ClinicalTrials.gov Identifier: NCT00226655
Recruitment Status : Completed
First Posted : September 27, 2005
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
Neurobiological Technologies
Information provided by (Responsible Party):
Celtic Pharma Development Services

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Edema
Brain Tumor
Intervention Drug: hCRF [XERECEPT (corticorelin acetate injection)]
Enrollment 112
Recruitment Details Recruitment started February 2005;
Pre-assignment Details Patients rolled-over from previous placebo controlled studies; open label study so no group assignment
Arm/Group Title hCRF
Hide Arm/Group Description All patients will receive hCRF (XERECEPT) 2mg/day
Period Title: Overall Study
Started 112
Completed 33
Not Completed 79
Reason Not Completed
Death             13
Withdrawal by Subject             15
Adverse Event             35
Physician Decision             6
Clinical deterioration             10
Arm/Group Title hCRF
Hide Arm/Group Description All patients will receive hCRF (XERECEPT) 2mg/day
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
<=18 years
0
   0.0%
Between 18 and 65 years
101
  90.2%
>=65 years
11
   9.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants
51.4  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
68
  60.7%
Male
44
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants
United States 101
Canada 6
Australia 4
New Zealand 1
1.Primary Outcome
Title Long Term Safety and Tolerability of hCRF
Hide Description Number of patients reporting adverse events
Time Frame Prospective
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title hCRF
Hide Arm/Group Description:
hCRF administered 1mg bid subcutaneously
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Participants
111
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title hCRF
Hide Arm/Group Description All patients will receive hCRF (XERECEPT) 2mg/day
All-Cause Mortality
hCRF
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
hCRF
Affected / at Risk (%) # Events
Total   72/112 (64.29%)    
Blood and lymphatic system disorders   
Anaemia   1/112 (0.89%)  1
Cardiac disorders   
Sinus tachycardia   1/112 (0.89%)  1
Supraventricular tachycardia   1/112 (0.89%)  1
Eye disorders   
Blindness   1/112 (0.89%)  1
Gastrointestinal disorders   
Diarrhoea   1/112 (0.89%)  1
Vomiting   1/112 (0.89%)  1
General disorders   
Asthenia   1/112 (0.89%)  1
Injection site urticaria   2/112 (1.79%)  2
Pain   1/112 (0.89%)  1
Hepatobiliary disorders   
Cholecystitis   1/112 (0.89%)  1
Cholelithiasis   1/112 (0.89%)  1
Infections and infestations   
Catheter related infection   1/112 (0.89%)  1
Cellulitis   4/112 (3.57%)  4
Clostridial infection   1/112 (0.89%)  1
Lower respiratory tract infection   1/112 (0.89%)  1
Perianal abscess   1/112 (0.89%)  1
Pneumonia   5/112 (4.46%)  5
Rectal abscess   1/112 (0.89%)  1
Sepsis   3/112 (2.68%)  3
Septic shock   2/112 (1.79%)  2
Tooth infection   1/112 (0.89%)  1
Upper respiratory tract infection   1/112 (0.89%)  1
Urinary tract infection   1/112 (0.89%)  1
Injury, poisoning and procedural complications   
Fall   4/112 (3.57%)  4
Fibula fracture   1/112 (0.89%)  1
Hip fracture   1/112 (0.89%)  1
Incisional hernia   1/112 (0.89%)  1
Ligament injury   1/112 (0.89%)  1
Rib fracture   2/112 (1.79%)  2
Splenic rupture   1/112 (0.89%)  1
Tibia fracture   1/112 (0.89%)  1
Wound   1/112 (0.89%)  1
Metabolism and nutrition disorders   
Gout   1/112 (0.89%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness   1/112 (0.89%)  1
Osteonecrosis   1/112 (0.89%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Astrocytoma   1/112 (0.89%)  1
Glioblastoma   2/112 (1.79%)  2
Glioblastoma multiforme   5/112 (4.46%)  5
Intracranial tumour haemorrhage   1/112 (0.89%)  1
Lung cancer metastatic   1/112 (0.89%)  1
Lung neoplasm malignant   1/112 (0.89%)  1
Metastases to lung   1/112 (0.89%)  1
Myelodysplastic syndrom   1/112 (0.89%)  1
Neoplasm progression   25/112 (22.32%)  25
Non-small cell lung cancer   1/112 (0.89%)  1
Tumour haemorrhage   1/112 (0.89%)  1
Nervous system disorders   
Aphasia   1/112 (0.89%)  1
Brain oedema   1/112 (0.89%)  1
Brain stem haemorrhage   1/112 (0.89%)  1
Cerebral haemorrhage   1/112 (0.89%)  1
Cerebrospinal fistula   1/112 (0.89%)  1
Convulsion   17/112 (15.18%)  17
Encephalopathy   1/112 (0.89%)  1
Haemorrhage intracranial   2/112 (1.79%)  2
Headache   3/112 (2.68%)  3
Status epilepticus   1/112 (0.89%)  1
Syncope   2/112 (1.79%)  2
Psychiatric disorders   
Agitation   8/112 (7.14%)  8
Confusional state   1/112 (0.89%)  1
Mental state changes   2/112 (1.79%)  2
Personality change   1/112 (0.89%)  1
Psychotic disorder   2/112 (1.79%)  2
Renal and urinary disorders   
Renal failure acute   2/112 (1.79%)  2
Rena tubular necrosis   1/112 (0.89%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia   1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure   1/112 (0.89%)  1
Dyspnoea   1/112 (0.89%)  1
Hypoxia   1/112 (0.89%)  1
Obstructive airways disorder   1/112 (0.89%)  1
Pleural effusion   2/112 (1.79%)  2
Pneumonia aspiration   1/112 (0.89%)  1
Pulmonary embolism   1/112 (0.89%)  1
Respiratory depression   5/112 (4.46%)  5
Respiratory failure   4/112 (3.57%)  4
Skin and subcutaneous tissue disorders   
Decubitus ulcer   1/112 (0.89%)  1
Vascular disorders   
Deep vein thrombosis   2/112 (1.79%)  2
Hypotension   1/112 (0.89%)  1
Venous thrombosis limb   1/112 (0.89%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
hCRF
Affected / at Risk (%) # Events
Total   111/112 (99.11%)    
Endocrine disorders   
Cushingoid   8/112 (7.14%)  8
Eye disorders   
Vision blurred   7/112 (6.25%)  7
Gastrointestinal disorders   
Diarrhoea   13/112 (11.61%)  13
Nausea   23/112 (20.54%)  23
Constipation   11/112 (9.82%)  11
Vomiting   12/112 (10.71%)  12
General disorders   
Injection site erythema   18/112 (16.07%)  18
Oedema peripheral   13/112 (11.61%)  13
Asthenia   7/112 (6.25%)  7
Fatigue   23/112 (20.54%)  23
Gait disturbance   8/112 (7.14%)  8
Infections and infestations   
Pneumonia   9/112 (8.04%)  9
Upper respiratory tract infection   9/112 (8.04%)  9
Urinary tract infection   8/112 (7.14%)  8
Injury, poisoning and procedural complications   
Contusion   7/112 (6.25%)  7
Fall   12/112 (10.71%)  12
Investigations   
Alanine aminotransferase increased   6/112 (5.36%)  6
Weight decreased   6/112 (5.36%)  6
Metabolism and nutrition disorders   
Anorexia   6/112 (5.36%)  6
Hyperglycaemia   8/112 (7.14%)  8
Musculoskeletal and connective tissue disorders   
Arthralgia   8/112 (7.14%)  8
Back pain   8/112 (7.14%)  8
Muscular weakness   14/112 (12.50%)  14
Musculoskeletal pain   6/112 (5.36%)  6
Pain in extremity   7/112 (6.25%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
glioblastoma multiforme   8/112 (7.14%)  8
Neoplasm progression   34/112 (30.36%)  34
Nervous system disorders   
Aphasia   9/112 (8.04%)  9
Convulsion   32/112 (28.57%)  32
Dizziness   8/112 (7.14%)  8
Headache   30/112 (26.79%)  30
Hemiparesis   15/112 (13.39%)  15
Hypoaesthesia   10/112 (8.93%)  10
Tremor   7/112 (6.25%)  7
Psychiatric disorders   
Confusional state   11/112 (9.82%)  11
Depression   6/112 (5.36%)  6
Insomnia   11/112 (9.82%)  11
Respiratory, thoracic and mediastinal disorders   
Cough   8/112 (7.14%)  8
Dyspnoea   8/112 (7.14%)  8
Skin and subcutaneous tissue disorders   
Rash   8/112 (7.14%)  8
Skin fragility   7/112 (6.25%)  7
Vascular disorders   
Flushing   27/112 (24.11%)  27
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Director Medical Sciences
Organization: Celtic Pharma Development Services America Inc
Phone: (212) 616 4016
Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00226655     History of Changes
Other Study ID Numbers: NTI 0501
First Submitted: September 23, 2005
First Posted: September 27, 2005
Results First Submitted: July 31, 2012
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012