A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

Ferring Pharmaceuticals3 sites in 3 countries120 target enrollmentDecember 2015

ConditionsProstate Cancer

Interventionsdegarelix

Drugsdegarelix

Overview

Phase: Phase 3
Intervention: degarelix
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Enrollment: 120
Locations: 3
Primary Endpoint: 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
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

June 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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/m
•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.

Arms & Interventions

Injection A

Degarelix s.c. standard injections

Intervention: degarelix

Injection B

Degarelix s.c. optimised injections

Intervention: degarelix

Injection C

Degarelix i.m. injections

Intervention: degarelix

Outcomes

Primary Outcomes

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

Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

Secondary Outcomes

Patient reported injection site pain scores after degarelix starting dose(From starting dose to 6 days after starting dose)
Patient reported injection site pain scores after degarelix maintenance doses(From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6))
Difference in skin colour values between pre- and post-injection(From baseline to month 6)