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Trial record 7 of 114 for:    centurion

Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00751790
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : June 13, 2012
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostatic Neoplasm
Intervention Drug: triptorelin embonate (INN)
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triptorelin
Hide Arm/Group Description Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
Period Title: Overall Study
Started 120
Completed 115
Not Completed 5
Reason Not Completed
Lost to Follow-up             1
Death             3
Withdrawal by Subject             1
Arm/Group Title Triptorelin
Hide Arm/Group Description Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
120
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants
71.11  (8.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
0
   0.0%
Male
120
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 120 participants
120
1.Primary Outcome
Title Achievement of Castration and Maintenance of Castration
Hide Description Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
Time Frame at Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triptorelin
Hide Arm/Group Description:
Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: percentage of enrolled patients
97.5
2.Secondary Outcome
Title LH Increase
Hide Description % of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts
Time Frame day 1 and day 169
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triptorelin
Hide Arm/Group Description Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
All-Cause Mortality
Triptorelin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Triptorelin
Affected / at Risk (%) # Events
Total   17/120 (14.17%)    
Cardiac disorders   
Acute myocardial infarction   1/120 (0.83%)  1
Angina pectoris   1/120 (0.83%)  1
Atrial flutter   1/120 (0.83%)  1
Myocardial infarction   1/120 (0.83%)  1
Endocrine disorders   
Diabetes mellitus   1/120 (0.83%)  1
Infections and infestations   
Pneumonia   1/120 (0.83%)  1
Injury, poisoning and procedural complications   
skin laceration   1/120 (0.83%)  1
Soft tissue injury   1/120 (0.83%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to bone   1/120 (0.83%)  1
Penis carcinoma   1/120 (0.83%)  1
Prostate cancer   2/120 (1.67%)  2
Prostate cancer metastatic   1/120 (0.83%)  1
Nervous system disorders   
Diabetic neuropathy   1/120 (0.83%)  1
Psychiatric disorders   
Depression   1/120 (0.83%)  1
Renal and urinary disorders   
Haematuria   1/120 (0.83%)  1
Obstructive uropathy   1/120 (0.83%)  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%
Triptorelin
Affected / at Risk (%) # Events
Total   115/120 (95.83%)    
General disorders   
Oedema peripheral   6/120 (5.00%)  6
Infections and infestations   
Bronchitis   6/120 (5.00%)  7
Influenza   19/120 (15.83%)  24
Musculoskeletal and connective tissue disorders   
Arthralgia   9/120 (7.50%)  9
Back pain   13/120 (10.83%)  17
Pain in extremity   9/120 (7.50%)  12
Nervous system disorders   
Headache   9/120 (7.50%)  9
Psychiatric disorders   
Insomnia   6/120 (5.00%)  7
Renal and urinary disorders   
Urinary retention   6/120 (5.00%)  10
Urinary tract infection   11/120 (9.17%)  14
Reproductive system and breast disorders   
Erectile dysfunction   12/120 (10.00%)  12
Testicular atrophy   9/120 (7.50%)  9
Vascular disorders   
Hot flush   87/120 (72.50%)  98
Hypertension   17/120 (14.17%)  18
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.
Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eija Lundström
Organization: Debiopharm S.A.
Phone: +41 21 3210111
EMail: elundstrom@debiopharm.com
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT00751790     History of Changes
Other Study ID Numbers: DEB-TRI6M-301
First Submitted: September 11, 2008
First Posted: September 12, 2008
Results First Submitted: December 21, 2009
Results First Posted: June 13, 2012
Last Update Posted: July 25, 2014