Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg (PAMIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01257425
First received: December 8, 2010
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: September 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients diagnosed with advanced prostate cancer (locally advanced or metastatic, histologically proven) recruited at 23 investigational sites in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
109 patients screened and 6 of these did not fulfil randomisation criteria therefore 103 patients were randomised to either group of treatment with triptorelin pamoate 3-month formulation applied intramuscularly or subcutaneously.

Reporting Groups
  Description
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.

Participant Flow:   Overall Study
    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.     Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.  
STARTED     52     51  
COMPLETED     46     45  
NOT COMPLETED     6     6  
Lack of Efficacy                 3                 3  
Adverse Event                 1                 1  
Protocol Violation                 1                 1  
Withdrawal by Subject                 0                 1  
Death                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysed from intent-to-treat (ITT) population comprised of 103 patients (SC: 52 and IM: 51 patients).

Reporting Groups
  Description
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
Total Total of all reporting groups

Baseline Measures
    Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.     Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.     Total  
Number of Participants  
[units: participants]
  52     51     103  
Age  
[units: years]
Mean ± Standard Deviation
  73.4  ± 6.7     73.3  ± 7.0     73.3  ± 6.8  
Age, Customized  
[units: participants]
     
50 to < 60 years     2     2     4  
60 to < 70 years     10     11     21  
70 to < 80 years     30     31     61  
80 to < 90 years     10     7     17  
Gender  
[units: participants]
     
Female     0     0     0  
Male     52     51     103  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     52     51     103  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Karnofsky index (%) [1]
[units: participants]
     
100%     21     27     48  
90%     18     12     30  
80%     13     12     25  
Prostate specific antigen (PSA) level [2]
[units: ng/mL]
Mean ± Standard Deviation
  47.1  ± 174.9     97.2  ± 368.0     71.7  ± 286.0  
Testosterone serum level [3]
[units: ng/mL]
Mean ± Standard Deviation
  3.23  ± 1.28     3.12  ± 1.36     3.18  ± 1.31  
Tumour-related pain [4]
[units: cm]
Mean ± Standard Deviation
  0.25  ± 0.58     0.37  ± 0.99     0.31  ± 0.81  
[1] Karnofsky index is a measure of performance status to quantify cancer patients' general well-being and activities of daily life. Karnofsky scores run from 100% (perfect health) to 0% (death). Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients).
[2] Analysed from Intent-to-treat (ITT) population with one missing value in the IM group.
[3] Analysed from Intent-to-treat (ITT) population comprised of 103 patients (SC:52 patients and IM:51 patients).
[4] Analysed from modified ITT population comprised of 98 patients (SC: 49 and IM: 49 patients). Tumour-related pain at baseline was rated by the patient by means of a 10-cm visual analogue scale (VAS), ranging from 0 (no pain) to 10 (maximum pain).



  Outcome Measures
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1.  Primary:   Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).   [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose ]

2.  Secondary:   Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)   [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ]

3.  Secondary:   Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)   [ Time Frame: 85, 87, 113, 141 and 169 days post-dose ]

4.  Secondary:   Maximum Concentration of Serum Testosterone [Cmax] - Raw Data   [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ]

5.  Secondary:   Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data   [ Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose ]

6.  Secondary:   Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL   [ Time Frame: 12 weeks ]

7.  Secondary:   Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Director, Uro-oncology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com


No publications provided


Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01257425     History of Changes
Other Study ID Numbers: A-94-52014-178, 2010-019632-12
Study First Received: December 8, 2010
Results First Received: September 27, 2013
Last Updated: April 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices