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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606021
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : December 26, 2011
Last Update Posted : December 26, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Drug: pemetrexed
Drug: Best Supportive Care
Enrollment 106
Recruitment Details  
Pre-assignment Details Induction phase (IP) is from first dose of study drug until randomization and entering to maintenance phase (MP) or discontinuation from treatment during IP. 106 participants were treated during IP. MP is from randomization to discontinuation from treatment. Overall period is IP+MP, whereas overall study is MP only.
Arm/Group Title Pemetrexed Plus Cisplatin (Induction Phase) Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles

Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Period Title: Induction Phase
Started 106 0 0
Completed 19 0 0
Not Completed 87 0 0
Reason Not Completed
Death             73             0             0
Physician Decision             2             0             0
Withdrawal by Subject             2             0             0
Lost to Follow-up             10             0             0
Period Title: Maintenance Phase
Started 0 28 27
Completed 0 5 10
Not Completed 0 23 17
Reason Not Completed
Death             0             17             15
Physician Decision             0             1             0
Lost to Follow-up             0             5             2
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase) Total
Hide Arm/Group Description

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. Total of all reporting groups
Overall Number of Baseline Participants 28 27 55
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 55 participants
57.4  (12.52) 62.9  (9.97) 60.1  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Female
8
  28.6%
10
  37.0%
18
  32.7%
Male
20
  71.4%
17
  63.0%
37
  67.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Caucasian 26 26 52
African 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Egypt 24 19 43
Saudi Arabia 0 1 1
Lebanon 4 7 11
Pathological Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Mixed Cell Carcinoma, Lung 1 1 2
Large Cells Lung Carcinoma 8 5 13
Adenocarcinoma 19 21 40
Stage of Disease at The Time of Entry into This Study  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Stage III B - Locally advanced 9 10 19
Stage IV - Metastasized 19 17 36
Eastern Cooperative Oncology Group (ECOG) Performance Status at randomization of maintenance phase   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
0 - Fully active 6 8 14
1 - Ambulatory, restricted strenuous activity 20 17 37
2 - Ambulatory, unable to carry out work activity 2 2 4
[1]
Measure Description: Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Lesion Response to induction phase   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Complete Response (CR) 0 1 1
Partial Response (PR) 10 11 21
Stable Disease (SD) 17 13 30
Unknown 1 2 3
[1]
Measure Description: The lesions response is classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Complete Response (CR): disappearance of all target lesions; Partial Response: (PR) ≥30% decrease in sum of longest diameter of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: ≥20% increase in sum of longest diameter of target lesions).
1.Primary Outcome
Title Progression Free Survival During Maintenance Phase
Hide Description Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
Time Frame Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Overall Number of Participants Analyzed 28 27
Median (95% Confidence Interval)
Unit of Measure: months
3.2
(2.9 to 6.1)
3.2
(2.2 to 4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Best Supportive Care (Maintenance Phase), Best Supportive Care (Maintenance Phase)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1815
Comments The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.
Method Regression, Cox
Comments Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.42 to 1.37
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Hide Description Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
Time Frame First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Overall Number of Participants Analyzed 28 27
Median (95% Confidence Interval)
Unit of Measure: months
6.2
(6.0 to 8.3)
6.0
(4.6 to 6.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Best Supportive Care (Maintenance Phase), Best Supportive Care (Maintenance Phase)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1233
Comments The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.
Method Regression, Cox
Comments Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.40 to 1.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival During Maintenance Phase
Hide Description Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Time Frame Randomization to PD or date of death from any cause up to 31.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Overall Number of Participants Analyzed 28 27
Median (95% Confidence Interval)
Unit of Measure: months
12.2
(5.6 to 20.6)
11.8
(6.3 to 25.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Best Supportive Care (Maintenance Phase), Best Supportive Care (Maintenance Phase)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7239
Comments The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.
Method Regression, Cox
Comments Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.56 to 2.28
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival During Overall Period (IP + MP)
Hide Description Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
Time Frame First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Overall Number of Participants Analyzed 28 27
Median (95% Confidence Interval)
Unit of Measure: months
15.4
(8.4 to 23.7)
16.4
(9.1 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Best Supportive Care (Maintenance Phase), Best Supportive Care (Maintenance Phase)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6376
Comments The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.
Method Regression, Cox
Comments Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.59 to 2.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) During Overall Period
Hide Description The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
Time Frame First dose of study drug during IP through overall study completion (up to 34.3) months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who took at least one dose of study drug during IP, and randomized to maintenance phase.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase) Pemetrexed Plus Cisplatin (Induction Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
Overall Number of Participants Analyzed 28 27 106
Measure Type: Number
Unit of Measure: participants
Adverse Events (AE) 15 16 74
Serious Adverse Events (SAE) 1 1 13
6.Secondary Outcome
Title Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Hide Description Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame Randomization to measured PD up to 31.4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.
Arm/Group Title Pemetrexed Plus Best Supportive Care (Maintenance Phase) Best Supportive Care (Maintenance Phase)
Hide Arm/Group Description:

Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Overall Number of Participants Analyzed 28 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Best Overall Response Rate
0
(0.0 to 12.3)
0
(0.0 to 12.8)
CR
0
(0 to 12.3)
0
(0 to 12.8)
PR
0
(0.0 to 12.3)
0
(0.0 to 12.8)
SD
57.1
(37.2 to 75.5)
44.4
(25.5 to 64.7)
Disease Control Rate
57.1
(37.2 to 75.5)
44.4
(25.5 to 64.7)
PD
32.1
(15.9 to 52.4)
37.0
(19.4 to 57.6)
Early Death From Malignant Disease
7.1
(0.9 to 23.5)
0
(0.0 to 12.8)
Early Death From Toxicity
0
(0.0 to 12.3)
0
(0.0 to 12.8)
Early Death From other cause
3.6
(0.1 to 18.3)
0
(0.0 to 12.8)
Unknown
0
(0.0 to 12.3)
18.5
(6.3 to 38.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events include pre-existing conditions.
 
Arm/Group Title Pemetrexed Plus Best Supportive Care - Maintenance Phase Best Supportive Care - Maintenance Phase Pemetrexed + Cisplatin - Induction Phase
Hide Arm/Group Description Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
All-Cause Mortality
Pemetrexed Plus Best Supportive Care - Maintenance Phase Best Supportive Care - Maintenance Phase Pemetrexed + Cisplatin - Induction Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Pemetrexed Plus Best Supportive Care - Maintenance Phase Best Supportive Care - Maintenance Phase Pemetrexed + Cisplatin - Induction Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      1/27 (3.70%)      13/106 (12.26%)    
Blood and lymphatic system disorders       
Anaemia  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Cardiac disorders       
Acute myocardial infarction  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Cardiac arrest  1  1/28 (3.57%)  1 0/27 (0.00%)  0 0/106 (0.00%)  0
Ear and labyrinth disorders       
Deafness  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Gastrointestinal disorders       
Diarrhoea  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Vomiting  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
General disorders       
Death  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Sudden death  1  0/28 (0.00%)  0 1/27 (3.70%)  1 2/106 (1.89%)  2
Investigations       
Weight decreased  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Nervous system disorders       
Altered state of consciousness  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Cerebrovascular accident  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Convulsion  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Diabetic ketoacidotic hyperglycaemic coma  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Psychiatric disorders       
Depression  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Reproductive system and breast disorders       
Ovarian cyst  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders       
Respiratory arrest  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Respiratory distress  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Vascular disorders       
Arterial thrombosis limb  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Circulatory collapse  1  0/28 (0.00%)  0 0/27 (0.00%)  0 1/106 (0.94%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed Plus Best Supportive Care - Maintenance Phase Best Supportive Care - Maintenance Phase Pemetrexed + Cisplatin - Induction Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/28 (53.57%)      16/27 (59.26%)      74/106 (69.81%)    
Blood and lymphatic system disorders       
Anaemia  1  5/28 (17.86%)  6 3/27 (11.11%)  3 14/106 (13.21%)  16
Lymphopenia  1  0/28 (0.00%)  0 0/27 (0.00%)  0 6/106 (5.66%)  6
Neutropenia  1  3/28 (10.71%)  11 1/27 (3.70%)  1 11/106 (10.38%)  16
Ear and labyrinth disorders       
Tinnitus  1  2/28 (7.14%)  2 0/27 (0.00%)  0 2/106 (1.89%)  2
Gastrointestinal disorders       
Gastritis  1  2/28 (7.14%)  2 1/27 (3.70%)  1 8/106 (7.55%)  10
Nausea  1  2/28 (7.14%)  4 0/27 (0.00%)  0 15/106 (14.15%)  20
Vomiting  1  2/28 (7.14%)  3 0/27 (0.00%)  0 35/106 (33.02%)  65
General disorders       
Chest pain  1  4/28 (14.29%)  5 3/27 (11.11%)  3 8/106 (7.55%)  9
Fatigue  1  3/28 (10.71%)  3 4/27 (14.81%)  4 25/106 (23.58%)  30
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/28 (0.00%)  0 2/27 (7.41%)  2 0/106 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  2/28 (7.14%)  2 1/27 (3.70%)  1 0/106 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  2/28 (7.14%)  2 3/27 (11.11%)  3 26/106 (24.53%)  36
Diabetes mellitus  1  1/28 (3.57%)  1 2/27 (7.41%)  2 5/106 (4.72%)  5
Hyperglycaemia  1  0/28 (0.00%)  0 2/27 (7.41%)  2 8/106 (7.55%)  9
Hyperkalaemia  1  0/28 (0.00%)  0 1/27 (3.70%)  1 6/106 (5.66%)  7
Hypokalaemia  1  2/28 (7.14%)  2 0/27 (0.00%)  0 1/106 (0.94%)  1
Hyponatraemia  1  1/28 (3.57%)  1 1/27 (3.70%)  1 8/106 (7.55%)  9
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/28 (3.57%)  1 4/27 (14.81%)  4 10/106 (9.43%)  12
Dyspnoea  1  3/28 (10.71%)  3 4/27 (14.81%)  4 9/106 (8.49%)  9
Vascular disorders       
Hypertension  1  2/28 (7.14%)  2 1/27 (3.70%)  1 5/106 (4.72%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Due to a mistake in the randomization parameters form, the randomization was actually implemented in the ratio of 1:1 instead of the planned ratio of 2:1.
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00606021    
Other Study ID Numbers: 11839
H3E-EZ-S114 ( Other Identifier: Eli Lilly and Company )
First Submitted: January 17, 2008
First Posted: February 1, 2008
Results First Submitted: October 3, 2011
Results First Posted: December 26, 2011
Last Update Posted: December 26, 2011