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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02526784 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
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Scientific title:
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A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02526784 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Finland
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France
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Germany
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged =18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all
stages) where endocrine treatment is indicated.
- Caucasian origin.
- Able to provide written Informed Consent and willing and able to comply with trial
procedures.
- Body mass index (BMI) between 18.5-30 kg/m2.
- Has a life expectancy of at least one year.
Exclusion Criteria:
- Current hormonal management of prostate cancer.
- Previous endocrine therapy for prostate cancer within 3 months prior to the screening
visit.
- Any medical injection therapy that might interfere with degarelix injections.
- Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion
would preclude or pose risks of complications following ventrogluteal i.m. injection
of degarelix.
- Any medical condition that could be aggravated or may cause extreme discomfort during
the trial period or could cause a moderate risk to a patient (significant heart, renal
or liver disease).
- Chronic pain syndrome or any continuous pain reported by the patient that, according
to the judgement of the Investigator, could limit the evaluation of injection related
pain.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: degarelix
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Primary Outcome(s)
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Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
[Time Frame: From baseline to month 6]
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Secondary Outcome(s)
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Patient reported injection site pain scores after degarelix starting dose
[Time Frame: From starting dose to 6 days after starting dose]
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Difference in skin colour values between pre- and post-injection
[Time Frame: From baseline to month 6]
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Patient reported injection site pain scores after degarelix maintenance doses
[Time Frame: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)]
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Secondary ID(s)
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2015-000357-20
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000184
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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