Protocol summary
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Study aim
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The main objective of this study is evaluating bio-equivalency of two sustained release Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer. As determining the blood level of this product is too complicated and could not be done by routine methods, measurement of biologic response to the medication, including serum Prostate Specific Antigen (PSA) and Testosterone levels, is recommended as surrogate of blood level to compare bio-equivalency of generic and brand forms of Triptorelin
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Design
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Two arm parallel group randomised trial
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Settings and conduct
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This study will be done in urology clinic of Shahid Labbafinejhad hospital and patients and physicians will be blinded to study arms
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Participants/Inclusion and exclusion criteria
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50 patients diagnosed with metastatic prostate cancer will be recruited after signing the written consent form
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Intervention groups
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Patients randomly (using random number table) will be assigned to brand (Diphereline, IPSEN, France) and generic forms of sustained release Triptorelin acetate (Decareline, Ronak Darou, Iran), on a 1:1 basis, 3.75mg by IM injection every 28 days for 3 months.
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Main outcome variables
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Prostate Specific Antigen (PSA) serum level
Testostrone serum level
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016090410178N10
Registration date:
2016-10-29, 1395/08/08
Registration timing:
registered_while_recruiting
Last update:
2018-07-28, 1397/05/06
Update count:
1
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Registration date
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2016-10-29, 1395/08/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Ronak Pharm
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Expected recruitment start date
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2016-10-22, 1395/08/01
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Expected recruitment end date
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2019-07-22, 1398/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparative bioequivalence study of two sustained release Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer based on biologic response (serum PSA and Testosterone levels)
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Public title
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Bioequivalence study of two Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Metastatic prostate cancer
Signing written consent form
Exclusion criteria:
Hypothalamic pituitary gonadal axis dysfunction
Malignancy other than prostate cancer
Treatment with other Gonadotropin Releasing Hormone (GnRH) analogues, hormones, radiotherapy or chemotherapy during recent three months
Allergy to GnRH, GnRH analogues or to any component of medications
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Age
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From 18 years old
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Gender
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Male
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
4
5 ml of venous blood
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done using individualized simple randomization method by Rnd function of Excel software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients who are candidate to receive triptorelin, based on physician's decision, will be referred to researcher and using pre-designed randomization table will be allocated in study arms.
Data will be send to data analyzer using codes and decoding will be done after completion of data analysis.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-20, 1395/04/30
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Ethics committee reference number
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IR.SBMU.PHNM.1395.408
Health conditions studied
1
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Description of health condition studied
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Metastatic prostate cancer
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ICD-10 code
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C61
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ICD-10 code description
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Malignant neoplasm of prostate
Primary outcomes
1
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Description
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Prostate Specific Antigen (PSA) serum level
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Timepoint
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Before injection of each dose of medication for 3 months
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Method of measurement
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Biomerieux Vidas kits
2
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Description
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Testostrone serum level
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Timepoint
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Before injection of each dose of medication for 3 months
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Method of measurement
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Biomerieux Vidas kits
Intervention groups
1
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Description
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Diphereline (Triptorelin acetate manufactured by IPSEN, France) 3.75mg IM every 28 days for 3 doses
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Category
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Treatment - Drugs
2
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Description
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Decareline (Triptorelin acetate manufactured by Ronak Darou, Iran) 3.75mg IM every 28 days for 3 doses
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ronak Pharm
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Data related to primary objectives
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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People working in academic institutions; pharmaceutical companies
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Under which criteria data/document could be used
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With official letter
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From where data/document is obtainable
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Mohammad Sistanizad
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What processes are involved for a request to access data/document
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Data are available 6 months after publication of results
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Comments
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