A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00967018 |
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Recruitment Status :
Completed
First Posted : August 27, 2009
Results First Posted : December 24, 2012
Last Update Posted : January 3, 2013
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Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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Brief Summary:
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: Degarelix | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 77 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer |
| Study Start Date : | August 2009 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | December 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
Drug Information available for:
Degarelix
| Arm | Intervention/treatment |
|---|---|
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Experimental: Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
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Drug: Degarelix |
Primary Outcome Measures :
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Up to 22.5 months ]The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Up to 22.5 months ]This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Other Outcome Measures:
- Serum Levels of Prostate Specific Antigen (PSA)Over Time [ Time Frame: from baseline to 72 weeks ]PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
- Serum Levels of Testosterone Over Time [ Time Frame: from baseline to week 72 ]Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
Exclusion Criteria:
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967018
Locations
Show 62 study locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00967018 |
| Other Study ID Numbers: |
FE200486 CS34 EudraCT No: 2008-006827-29 |
| First Posted: | August 27, 2009 Key Record Dates |
| Results First Posted: | December 24, 2012 |
| Last Update Posted: | January 3, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Ferring Pharmaceuticals:
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Safety parameters ECG, blood and urine samples general health state |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |