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Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00738673
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: degarelix
Enrollment 37
Recruitment Details Cohort 1 comprised a broad spectrum of biochemically relapsed participants (on castrate level) on long term hormonal treatment in different stages of the disease (primarily advance stages), however not in need of chemotherapy. The second cohort was similar, although testosterone levels were to be above castrate level (≥0.32 ng/mL).
Pre-assignment Details  
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections. Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Period Title: Overall Study
Started 25 12
Intent to Treat Population 24 12
Completed 1 1
Not Completed 24 11
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             19             8
Protocol Violation             1             2
Withdrawal by Subject             3             1
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2 Total
Hide Arm/Group Description Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections. Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections. Total of all reporting groups
Overall Number of Baseline Participants 24 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 12 participants 36 participants
72.7  (9.11) 76.5  (4.68) 73.9  (8.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
12
 100.0%
36
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Not Hispanic or Latino 24 12 36
HIspanic or Latino 0 0 0
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
White 24 12 36
Other 0 0 0
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants 12 participants 36 participants
90.5  (17.3) 87.6  (11.0) 89.6  (15.5)
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 24 participants 12 participants 36 participants
1.74  (0.06) 1.72  (0.05) 1.73  (0.06)
Stage of Prostate Cancer at Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Localized 4 4 8
Locally advanced 11 1 12
Metastatic 6 2 8
Not classifiable 3 5 8
Stage of Prostate Cancer at Enrolment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Localized 1 2 3
Locally advanced 9 0 9
Metastatic 7 5 12
Not classifiable 7 5 12
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
2-4 1 3 4
5-6 4 2 6
7-10 19 7 26
[1]
Measure Description: The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a Gleason Score with a range of 2-10; 10=worst prognosis.
Eastern Cooporative Oncology Group (ECOG) Performance Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Fully active 0 0 0
Restricted, but ambulatory 17 11 28
Ambulatory, unable to work 7 1 8
Capable of only limited selfcare 0 0 0
Completely disabled 0 0 0
1.Primary Outcome
Title Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
Hide Description

Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level
Time Frame Day 0 (baseline), 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Last observation carried forward.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Response
16.67
(4.74 to 37.38)
33.33
(9.92 to 65.11)
No Response
83.33
(62.62 to 95.26)
66.67
(34.89 to 90.08)
2.Secondary Outcome
Title Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
Hide Description

Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level.

Per protocol, the one month timeframe was only analyzed for cohort 2.

Time Frame Day 0 (baseline), 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 0 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Response
66.67
(29.93 to 92.51)
No Response
33.33
(7.49 to 70.07)
3.Secondary Outcome
Title Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
Hide Description

Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level.

Per protocol, the two month timeframe was only analyzed for cohort 2.

Time Frame Day 0 (baseline), 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 0 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Response
40.00
(12.16 to 73.76)
No Response
60.00
(26.24 to 87.84)
4.Secondary Outcome
Title Participants at Testosterone Castrate Level Throughout the Study
Hide Description Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
Time Frame up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: participants
24 11
5.Secondary Outcome
Title Change From Baseline in Serum Levels of Testosterone at the Last Visit
Hide Description [Not Specified]
Time Frame Day 0 (baseline), up to month 12 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.039  (0.175) -0.038  (0.631)
6.Secondary Outcome
Title Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
Hide Description [Not Specified]
Time Frame Day 0 (baseline), up to month 12 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
18  (29) 54  (116)
7.Secondary Outcome
Title Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
Hide Description LH is measured in IU/L
Time Frame Day 0 (baseline), up to month 12 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 9
Mean (Standard Deviation)
Unit of Measure: percentage of baseline
58  (286) 123  (277)
8.Secondary Outcome
Title Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
Hide Description [Not Specified]
Time Frame Day 0 (baseline), up to month 12 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population with a baseline and at least one scheduled post-baseline measurement.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 9
Mean (Standard Deviation)
Unit of Measure: IU/L
-1.64  (3.01) -2.01  (1.72)
9.Secondary Outcome
Title Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
Hide Description Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
Time Frame up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 0 12
Measure Type: Number
Unit of Measure: participants
8
10.Secondary Outcome
Title Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
Hide Description Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
Time Frame up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 0 12
Measure Type: Number
Unit of Measure: participants
9
11.Secondary Outcome
Title Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
Hide Description Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.
Time Frame up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: participants
21 11
12.Secondary Outcome
Title Kaplan-Meier Estimate for Overall Survival
Hide Description The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient’s data were censored at the date of last visit.
Time Frame up to month 12
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat population.

Analysis was not performed since no participants died during study.

Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description:
Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to month 13
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Degarelix - Cohort 1 Degarelix - Cohort 2
Hide Arm/Group Description Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections. Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
All-Cause Mortality
Degarelix - Cohort 1 Degarelix - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix - Cohort 1 Degarelix - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   3/25 (12.00%)   1/12 (8.33%) 
Blood and lymphatic system disorders     
Anaemia of malignant disease  1  0/25 (0.00%)  1/12 (8.33%) 
Anaemia  1  0/25 (0.00%)  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/25 (4.00%)  0/12 (0.00%) 
Nervous system disorders     
Carotid artery stenosis  1  1/25 (4.00%)  0/12 (0.00%) 
Renal and urinary disorders     
Bladder tamponade  1  1/25 (4.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix - Cohort 1 Degarelix - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   18/25 (72.00%)   10/12 (83.33%) 
Gastrointestinal disorders     
Constipation  1  0/25 (0.00%)  1/12 (8.33%) 
Stomach discomfort  1  0/25 (0.00%)  1/12 (8.33%) 
Vomiting  1  0/25 (0.00%)  1/12 (8.33%) 
General disorders     
Injection site erythema  1  10/25 (40.00%)  6/12 (50.00%) 
Injection site swelling  1  8/25 (32.00%)  5/12 (41.67%) 
Injection site pain  1  3/25 (12.00%)  0/12 (0.00%) 
Injection site induration  1  2/25 (8.00%)  0/12 (0.00%) 
General physical health deterioration  1  0/25 (0.00%)  1/12 (8.33%) 
Pyrexia  1  0/25 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Urinary tract infection  1  1/25 (4.00%)  1/12 (8.33%) 
Bronchitis  1  0/25 (0.00%)  1/12 (8.33%) 
Gastroenteritis  1  0/25 (0.00%)  1/12 (8.33%) 
Rhinitis  1  0/25 (0.00%)  1/12 (8.33%) 
Investigations     
Weight increase  1  0/25 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
Hyperlipidaemia  1  0/25 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis  1  0/25 (0.00%)  1/12 (8.33%) 
Pain in extremity  1  0/25 (0.00%)  1/12 (8.33%) 
Psychiatric disorders     
Insomnia  1  0/25 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/25 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Hot flush  1  2/25 (8.00%)  0/12 (0.00%) 
Venous stasis  1  0/25 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00738673     History of Changes
Other Study ID Numbers: FE200486 CS27
2008-000585-22 ( EudraCT Number )
First Submitted: August 18, 2008
First Posted: August 20, 2008
Results First Submitted: December 12, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013