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To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia

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ClinicalTrials.gov Identifier: NCT00589693
Recruitment Status : Terminated (Observed lower cure rates and higher mortality rates in one of the treatment groups.)
First Posted : January 10, 2008
Results First Posted : July 18, 2012
Last Update Posted : December 28, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ventilator-Associated Pneumonia
Interventions Drug: Doripenem
Drug: Imipenem-Cilastatin
Drug: Placebo
Enrollment 274

Recruitment Details 274 enrolled patients were randomnly assigned to the 127 study centers. 524 patients were to be enrolled, however as the study was terminated early only 274 patients were actually enrolled.
Pre-assignment Details Out of 274 randomized patients, 41 patients were excluded (as their sites were GCP Non-Compliant) and 6 patients were not treated. Treated patients=227 (115 doripenem and 112 imipenem-cilastatin).
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description 1 g 4-hour infusion intravenously every 8 hour for 7 days 1 g 1-hour infusion intravenously every 8 hour for 10 days
Period Title: Overall Study
Started 115 112
Completed 71 83
Not Completed 44 29
Reason Not Completed
randomized in error             12             6
Adverse Event             4             4
Death             26             16
Lack of Efficacy             0             1
Lost to Follow-up             1             0
Physician Decision             0             1
Protocol Violation             1             1
Arm/Group Title Doripenem Imipenem-cilastatin Total
Hide Arm/Group Description 1 g 4-hour infusion intravenously every 8 hour for 7 days 1 g 1-hour infusion intravenously every 8 hour for 10 days Total of all reporting groups
Overall Number of Baseline Participants 115 112 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
<=18 years
0
   0.0%
1
   0.9%
1
   0.4%
Between 18 and 65 years
72
  62.6%
72
  64.3%
144
  63.4%
>=65 years
43
  37.4%
39
  34.8%
82
  36.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 112 participants 227 participants
57.5  (16.53) 54.6  (18.46) 56.1  (17.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
Female
43
  37.4%
37
  33.0%
80
  35.2%
Male
72
  62.6%
75
  67.0%
147
  64.8%
Region Enroll  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 112 participants 227 participants
EUROPE 69 71 140
NORTH AMERICA 16 12 28
REST OF WORLD 9 6 15
SOUTH AMERICA 21 23 44
1.Primary Outcome
Title Clinical Cure Rate at the End-of-treatment (EOT) Visit
Hide Description The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.
Time Frame End-of-treatment (Day 10 or Day 11)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description:
1 g 4-hour infusion intravenously every 8 hour for 7 days
1 g 1-hour infusion intravenously every 8 hour for 10 days
Overall Number of Participants Analyzed 79 88
Measure Type: Number
Unit of Measure: Participants
36 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doripenem, Imipenem-cilastatin
Comments Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation of 2 proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of 2 binomial proportions
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-26.3 to 3.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline
Hide Description The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.
Time Frame End-of-treatment (Day 10 or Day 11)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description:
1 g 4-hour infusion intravenously every 8 hour for 7 days
1 g 1-hour infusion intravenously every 8 hour for 10 days
Overall Number of Participants Analyzed 17 10
Measure Type: Number
Unit of Measure: Participants
7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doripenem, Imipenem-cilastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation of 2 proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of 2 binomial proportions
Estimated Value -18.8
Confidence Interval (2-Sided) 95%
-57.2 to 19.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline
Hide Description The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.
Time Frame End-of-treatment (Day 10 or Day 11)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description:
1 g 4-hour infusion intravenously every 8 hour for 7 days
1 g 1-hour infusion intravenously every 8 hour for 10 days
Overall Number of Participants Analyzed 65 62
Measure Type: Number
Unit of Measure: Participants
32 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doripenem, Imipenem-cilastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation of 2 proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of 2 binomial proportions
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-23.0 to 11.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients Who Had Emergence of P. Aeruginosa Resistance
Hide Description Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline
Time Frame Up to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description:
1 g 4-hour infusion intravenously every 8 hour for 7 days
1 g 1-hour infusion intravenously every 8 hour for 10 days
Overall Number of Participants Analyzed 19 15
Measure Type: Number
Unit of Measure: Participants
3 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doripenem, Imipenem-cilastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title 28-day All-cause Mortality Rate
Hide Description Number of deaths which occured up to 28 days of the study period due to all causes
Time Frame Up to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description:
1 g 4-hour infusion intravenously every 8 hour for 7 days
1 g 1-hour infusion intravenously every 8 hour for 10 days
Overall Number of Participants Analyzed 79 88
Measure Type: Number
Unit of Measure: Participants
17 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doripenem, Imipenem-cilastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation of 2 proportions
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of 2 binomial proportions
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-5.0 to 18.5
Estimation Comments [Not Specified]
Time Frame 6 weeks
Adverse Event Reporting Description Only patients who had at least one of the treatment related adverse events (AEs) was listed in the other (non Serious) AE table and was included as the total number of patients with Non-Serious Adverse Events.
 
Arm/Group Title Doripenem Imipenem-cilastatin
Hide Arm/Group Description 1 g 4-hour infusion intravenously every 8 hour for 7 days 1 g 1-hour infusion intravenously every 8 hour for 10 days
All-Cause Mortality
Doripenem Imipenem-cilastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doripenem Imipenem-cilastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   55/115 (47.83%)   45/112 (40.18%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/115 (0.87%)  0/112 (0.00%) 
Cardiac disorders     
Cardiac arrest * 1  3/115 (2.61%)  6/112 (5.36%) 
Cardiac failure * 1  2/115 (1.74%)  3/112 (2.68%) 
Atrial fibrillation * 1  1/115 (0.87%)  0/112 (0.00%) 
Bradyarrhythmia * 1  1/115 (0.87%)  0/112 (0.00%) 
Cardio-respiratory arrest * 1  1/115 (0.87%)  0/112 (0.00%) 
Ventricular fibrillation * 1  1/115 (0.87%)  0/112 (0.00%) 
Bradycardia * 1  0/115 (0.00%)  2/112 (1.79%) 
Endocrine disorders     
Diabetes insipidus * 1  1/115 (0.87%)  0/112 (0.00%) 
Gastrointestinal disorders     
Duodenal perforation * 1  1/115 (0.87%)  0/112 (0.00%) 
Gastrointestinal haemorrhage * 1  1/115 (0.87%)  0/112 (0.00%) 
Pancreatic necrosis * 1  1/115 (0.87%)  0/112 (0.00%) 
Pancreatitis * 1  1/115 (0.87%)  0/112 (0.00%) 
Peritonitis * 1  1/115 (0.87%)  1/112 (0.89%) 
Diarrhoea * 1  0/115 (0.00%)  1/112 (0.89%) 
Gastric haemorrhage * 1  0/115 (0.00%)  1/112 (0.89%) 
Ileus paralytic * 1  0/115 (0.00%)  1/112 (0.89%) 
Lower gastrointestinal haemorrhage * 1  0/115 (0.00%)  1/112 (0.89%) 
General disorders     
Multi-organ failure * 1  2/115 (1.74%)  3/112 (2.68%) 
Treatment failure * 1  2/115 (1.74%)  0/112 (0.00%) 
Impaired healing * 1  0/115 (0.00%)  1/112 (0.89%) 
Hepatobiliary disorders     
Cholecystitis * 1  1/115 (0.87%)  1/112 (0.89%) 
Immune system disorders     
Hypersensitivity * 1  1/115 (0.87%)  0/112 (0.00%) 
Infections and infestations     
Sepsis * 1  8/115 (6.96%)  3/112 (2.68%) 
Septic shock * 1  6/115 (5.22%)  6/112 (5.36%) 
Pneumonia * 1  5/115 (4.35%)  3/112 (2.68%) 
Device related sepsis * 1  3/115 (2.61%)  2/112 (1.79%) 
Urinary tract infection * 1  3/115 (2.61%)  1/112 (0.89%) 
Empyema * 1  2/115 (1.74%)  0/112 (0.00%) 
Abscess * 1  1/115 (0.87%)  0/112 (0.00%) 
Bacteraemia * 1  1/115 (0.87%)  2/112 (1.79%) 
Central nervous system infection * 1  1/115 (0.87%)  0/112 (0.00%) 
Clostridium difficile colitis * 1  1/115 (0.87%)  0/112 (0.00%) 
Infected skin ulcer * 1  1/115 (0.87%)  0/112 (0.00%) 
Osteomyelitis * 1  1/115 (0.87%)  1/112 (0.89%) 
Pneumonia bacterial * 1  1/115 (0.87%)  0/112 (0.00%) 
Staphylococcal sepsis * 1  1/115 (0.87%)  0/112 (0.00%) 
Staphylococcal skin infection * 1  1/115 (0.87%)  0/112 (0.00%) 
Superinfection * 1  1/115 (0.87%)  0/112 (0.00%) 
Abdominal abscess * 1  0/115 (0.00%)  1/112 (0.89%) 
Device related infection * 1  0/115 (0.00%)  1/112 (0.89%) 
Fungal infection * 1  0/115 (0.00%)  1/112 (0.89%) 
Lung infection * 1  0/115 (0.00%)  1/112 (0.89%) 
Mediastinitis * 1  0/115 (0.00%)  2/112 (1.79%) 
Meningitis * 1  0/115 (0.00%)  1/112 (0.89%) 
Pneumonia klebsiella * 1  0/115 (0.00%)  1/112 (0.89%) 
Postoperative wound infection * 1  0/115 (0.00%)  1/112 (0.89%) 
Pulmonary sepsis * 1  0/115 (0.00%)  2/112 (1.79%) 
Tracheobronchitis * 1  0/115 (0.00%)  1/112 (0.89%) 
Injury, poisoning and procedural complications     
Traumatic brain injury * 1  3/115 (2.61%)  0/112 (0.00%) 
Fat embolism * 1  1/115 (0.87%)  0/112 (0.00%) 
Incisional hernia * 1  1/115 (0.87%)  0/112 (0.00%) 
Post procedural complication * 1  1/115 (0.87%)  0/112 (0.00%) 
Anaemia postoperative * 1  0/115 (0.00%)  1/112 (0.89%) 
Extradural haematoma * 1  0/115 (0.00%)  1/112 (0.89%) 
Post procedural haemorrhage * 1  0/115 (0.00%)  1/112 (0.89%) 
Spinal cord injury cervical * 1  0/115 (0.00%)  1/112 (0.89%) 
Investigations     
Troponin increased * 1  1/115 (0.87%)  0/112 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/115 (0.00%)  1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to pleura * 1  1/115 (0.87%)  0/112 (0.00%) 
Nervous system disorders     
Brain oedema * 1  3/115 (2.61%)  4/112 (3.57%) 
Intracranial pressure increased * 1  2/115 (1.74%)  1/112 (0.89%) 
Brain stem syndrome * 1  1/115 (0.87%)  0/112 (0.00%) 
Convulsion * 1  1/115 (0.87%)  0/112 (0.00%) 
Haemorrhage intracranial * 1  1/115 (0.87%)  0/112 (0.00%) 
Nervous system disorder * 1  1/115 (0.87%)  0/112 (0.00%) 
Subarachnoid haemorrhage * 1  1/115 (0.87%)  0/112 (0.00%) 
Cerebrovascular accident * 1  0/115 (0.00%)  1/112 (0.89%) 
Hydrocephalus * 1  0/115 (0.00%)  1/112 (0.89%) 
Subdural hygroma * 1  0/115 (0.00%)  1/112 (0.89%) 
Transient ischaemic attack * 1  0/115 (0.00%)  1/112 (0.89%) 
Renal and urinary disorders     
Renal failure * 1  5/115 (4.35%)  1/112 (0.89%) 
Renal failure acute * 1  2/115 (1.74%)  2/112 (1.79%) 
Acute prerenal failure * 1  1/115 (0.87%)  0/112 (0.00%) 
Renal tubular acidosis * 1  0/115 (0.00%)  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  3/115 (2.61%)  2/112 (1.79%) 
Acute respiratory distress syndrome * 1  2/115 (1.74%)  1/112 (0.89%) 
Acute respiratory failure * 1  1/115 (0.87%)  2/112 (1.79%) 
Atelectasis * 1  1/115 (0.87%)  1/112 (0.89%) 
Pleural effusion * 1  1/115 (0.87%)  1/112 (0.89%) 
Pulmonary embolism * 1  1/115 (0.87%)  3/112 (2.68%) 
Pulmonary haemorrhage * 1  1/115 (0.87%)  0/112 (0.00%) 
Respiratory arrest * 1  1/115 (0.87%)  1/112 (0.89%) 
Respiratory disorder * 1  1/115 (0.87%)  0/112 (0.00%) 
Respiratory distress * 1  1/115 (0.87%)  0/112 (0.00%) 
Acute pulmonary oedema * 1  0/115 (0.00%)  1/112 (0.89%) 
Apnoea * 1  0/115 (0.00%)  1/112 (0.89%) 
Hypoxia * 1  0/115 (0.00%)  4/112 (3.57%) 
Pleural disorder * 1  0/115 (0.00%)  1/112 (0.89%) 
Pulmonary oedema * 1  0/115 (0.00%)  1/112 (0.89%) 
Tachypnoea * 1  0/115 (0.00%)  1/112 (0.89%) 
Skin and subcutaneous tissue disorders     
Skin haemorrhage * 1  1/115 (0.87%)  0/112 (0.00%) 
Vascular disorders     
Circulatory collapse * 1  1/115 (0.87%)  0/112 (0.00%) 
Deep vein thrombosis * 1  1/115 (0.87%)  0/112 (0.00%) 
Hypovolaemic shock * 1  1/115 (0.87%)  0/112 (0.00%) 
Intra-abdominal haemorrhage * 1  1/115 (0.87%)  0/112 (0.00%) 
Shock * 1  1/115 (0.87%)  2/112 (1.79%) 
Haemorrhage * 1  0/115 (0.00%)  1/112 (0.89%) 
Hypotension * 1  0/115 (0.00%)  3/112 (2.68%) 
Jugular vein thrombosis * 1  0/115 (0.00%)  1/112 (0.89%) 
Thrombosis * 1  0/115 (0.00%)  1/112 (0.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doripenem Imipenem-cilastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   82/115 (71.30%)   80/112 (71.43%) 
Blood and lymphatic system disorders     
Anaemia * 1  26/115 (22.61%)  25/112 (22.32%) 
Cardiac disorders     
Atrial fibrillation * 1  9/115 (7.83%)  8/112 (7.14%) 
Bradycardia * 1  3/115 (2.61%)  6/112 (5.36%) 
Gastrointestinal disorders     
Diarrhoea * 1  11/115 (9.57%)  12/112 (10.71%) 
Constipation * 1  9/115 (7.83%)  11/112 (9.82%) 
Vomiting * 1  6/115 (5.22%)  6/112 (5.36%) 
Nausea * 1  5/115 (4.35%)  7/112 (6.25%) 
General disorders     
Pyrexia * 1  11/115 (9.57%)  10/112 (8.93%) 
Infections and infestations     
Urinary tract infection * 1  13/115 (11.30%)  16/112 (14.29%) 
Pneumonia * 1  6/115 (5.22%)  9/112 (8.04%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  12/115 (10.43%)  12/112 (10.71%) 
Hyperkalaemia * 1  6/115 (5.22%)  6/112 (5.36%) 
Hypernatraemia * 1  5/115 (4.35%)  7/112 (6.25%) 
Hyponatraemia * 1  5/115 (4.35%)  10/112 (8.93%) 
Hypomagnesaemia * 1  4/115 (3.48%)  7/112 (6.25%) 
Psychiatric disorders     
Depression * 1  14/115 (12.17%)  8/112 (7.14%) 
Agitation * 1  11/115 (9.57%)  7/112 (6.25%) 
Insomnia * 1  8/115 (6.96%)  8/112 (7.14%) 
Anxiety * 1  2/115 (1.74%)  6/112 (5.36%) 
Renal and urinary disorders     
Renal impairment * 1  6/115 (5.22%)  4/112 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  4/115 (3.48%)  6/112 (5.36%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  14/115 (12.17%)  11/112 (9.82%) 
Vascular disorders     
Hypotension * 1  11/115 (9.57%)  8/112 (7.14%) 
Hypertension * 1  2/115 (1.74%)  6/112 (5.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
41 patients (21 doripenem, 20 imipenem-cilastatin) were enrolled at 5 sites that were found to be Good Clinical Practice non-compliant and were excluded from the primary efficacy and safety analyses.
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: Sr Director Clinical Development
Organization: Janssen R&D US
Phone: 1 510 248-2310
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00589693     History of Changes
Other Study ID Numbers: CR014038
DORINOS3008 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2007-004646-33 ( EudraCT Number )
First Submitted: December 21, 2007
First Posted: January 10, 2008
Results First Submitted: June 13, 2012
Results First Posted: July 18, 2012
Last Update Posted: December 28, 2012