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)
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.
In this double blinded, single center, randomized clinical trial, 100 patients diagnosed with high risk, stage 4 metastatic prostate cancer with Gleason score (GS)>8 and PSA >20, will be recruited. After signing the written consent form, 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. Before injection of each dose of medication, blood sample for measurement of PSA and Testosterone serum level, using Vidas kits manufactured by Biomerieux- France, will be collected from subjects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090410178N10
Registration date:2016-10-29, 1395/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-10-29, 1395/08/08
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Ronak Pharm
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
Bioequivalence study of two Triptorelin vials manufactured by Ronak Darou and IPSEN in patients with prostate cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Metastatic prostate cancer; Gleason score (GS)>=8 and PSA>20; Non-operable; Signing written consent form
Exclusion criteria: Hypothalamic pituitary gonadal axis dysfunction; Treatment with other Gonadotropin Releasing Hormone (GnRH) analogues, hormones, radiotherapy or chemotherapy during recent three months; Malignancy other than prostate cancer; Urinary retention or spinal cord injury; Cooperating in other study; Addiction to opioids; Allergy to GnRH, GnRH analogues or to any component of medications; severe coagulopathy including INR>2 or Plt <80,000; Osteoporosis
Age
From 18 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using simple randomization method by Rnd function of Excel software.
In order to run the study in double blinded manner, the study medications will be packed and labeled by Ronak Darou in identical containers. Researchers and patients are not aware of the codes. At the end of the study all data will be analyzed by A and B codes and will be send to researcher who is responsible for scientific inquiries of the study. Then the medications will be decoded. Finally data will be send to Ronak Darou.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.SBMU.PHNM.1395.408
Health conditions studied
1
Description of health condition studied
Metastatic prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Prostate Specific Antigen (PSA) serum level
Timepoint
Before injection of each dose of medication for 3 months
Method of measurement
Biomerieux Vidas kits
2
Description
Testostrone serum level
Timepoint
Before injection of each dose of medication for 3 months
Method of measurement
Biomerieux Vidas kits
Secondary outcomes
empty
Intervention groups
1
Description
Diphereline (Triptorelin acetate manufactured by IPSEN, France) 3.75mg IM every 28 days for 3 doses
Category
Treatment - Drugs
2
Description
Decareline (Triptorelin acetate manufactured by Ronak Darou, Iran) 3.75mg IM every 28 days for 3 doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic, Shahid Labbafinejad hospital
Full name of responsible person
Shadi Ziaei
Street address
9th Boostan St., Pasdaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences University of Medical S
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences University of Medical S
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 218800087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 218800087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 218800087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)