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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-005058-31-NL
Date of registration:	21/07/2006
Prospective Registration:	Yes
Primary sponsor:	IPSEN FARMACEUTICA BV
Public title:	PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP STUDY TO ASSESS THE NON-INFERIORITY OF PAMORELIN® 11,25MG SC INJECTED VERSUS PAMORELIN® 11,25MG IM INJECTED IN PATIENTS SUFFERING FROM ADVANCED PROSTATE CANCER - PAMOJECT
Scientific title:	PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP STUDY TO ASSESS THE NON-INFERIORITY OF PAMORELIN® 11,25MG SC INJECTED VERSUS PAMORELIN® 11,25MG IM INJECTED IN PATIENTS SUFFERING FROM ADVANCED PROSTATE CANCER - PAMOJECT
Date of first enrolment:	22/12/2006
Target sample size:	210
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005058-31
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Pamorelin 11,25 IM injected
Phase:

Countries of recruitment
Netherlands

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1) Provision of written informed consent prior to any study related procedures.
2) Male patients aged 18 years and older
3) Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy.
4) Life expectancy of more than 9 months
5) Documented testosterone levels of = 125 ng/dl measured by any laboratory or on site within the previous 6 months
6) Patient able and willing to comply with the requirements of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Has a history of hypersensitivity to the studied drug or drugs with a similar chemical structure.
2) Was treated with any other Investigational Medicinal Product within the last 30 days before study entry.
3) Has previously received a GnRH analogue, estrogens or a steroidal anti –androgen within the last year preceding the study.
4) Concomitant anti-coagulation treatment.
5) Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study.
6) Patient with known spinal medullar compression.
7) Has a history of, or known current, problems with alcohol abuse.
8) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
9) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Patients with advanced (locally or metastatic) prostate cancer scheduled to receive an LHRH analogue as androgen deprivation therapy

Intervention(s)

Product Name: Pamorelin 11,25mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: triptorelin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 11,25-

Primary Outcome(s)

Main Objective: To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level = 50 ng/dl at week 24.

Secondary Objective: Overall patient acceptability of SC vs IM injection of Pamorelin® 11,25 mg
Overall caregiver acceptability of SC vs IM injection of Pamorelin® 11,25 mg
To assess the tolerability and safety of SC and IM injections of Pamorelin® 11,25 mg
To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via SC injection as compared to Pamorelin® 11,25 mg administered via standard IM injection based on the percentage of patients presenting a testosterone level = 50 ng/dl at week 12

Primary end point(s): Primary Efficacy Variables:
Percentage of patients achieving a plasma testosterone level = 50 ng/dl (1,7 nmol/l) measured at week 24

Secondary Outcome(s)

Secondary ID(s)

I-48-52014-142

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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