Protocol summary
-
Study aim
-
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
-
Design
-
A randomized, two treatment, one period, parallel study
-
Settings and conduct
-
This study will be done in Mehr and Imam Khomeini hospitals. 40 Patients with advanced prostate cancer will participate. They will receive a dose of 3.75 mg of triptorelin. Five mL of blood samples will be obtained at 0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration. This is a single blind and parallel study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion:
Patients with Prostate Cancer
Availability of the patient for the entire study period and show willingness to adhere to study requirements
Able to give written consent
Exclusion:
History of hypersensitivity to the study drug
History of previous chemotherapy
Renal (serum creatinine twice normal) and hepatic failure (AST and ALT three times normal
Administration of corticosteroids except for topical use
Donation of blood or plasma thirty days before the first day of this study
Vaccination one month before the first day of the study
Participation in a clinical trial one month before the first day of the study
-
Intervention groups
-
Single dose administration of injectable sustained release formulations of Triptorelin (Decatrip® or Dipherelin®) in Patients with prostate cancer
-
Main outcome variables
-
Drug concentration in serum
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20130603013572N8
Registration date:
2024-03-21, 1403/01/02
Registration timing:
prospective
Last update:
2025-03-03, 1403/12/13
Update count:
1
-
Registration date
-
2024-03-21, 1403/01/02
-
Registrant information
-
-
Recruitment status
-
recruiting
-
Funding source
-
-
Expected recruitment start date
-
2024-04-03, 1403/01/15
-
Expected recruitment end date
-
2026-03-11, 1404/12/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
-
Public title
-
Bioequivalence study of two injectable sustained release formulations of Triptorelin (Decatrip® and Dipherelin®) in Patients with prostate cancer
-
Purpose
-
Other
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with Prostate Cancer
Availability of the patient for the entire study period and show willingness to adhere to study requirements
Able to give written consent
Exclusion criteria:
History of hypersensitivity to the study drug
History of previous chemotherapy
Renal (serum creatinine twice normal) and hepatic failure (AST and ALT three times normal)
Administration of corticosteroids except for topical use
Donation of blood or plasma thirty days before the first day of this study
Vaccination one month before the first day of the study
Participation in a clinical trial one month before the first day of the study
-
Age
-
To 65 years old
-
Gender
-
Male
-
Phase
-
Bioequivalence
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
40
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple randomization
Administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to entrancing of subject to the study. Each subject is identified by a number from 1 to 40 according to entrancing of subject to the study. Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug. (test or reference is the same drug but produced with different manufacturers).
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The study is a single-blind. Patients are blind in this study. Patients are aware of what medication they are taking but do not know whether they are taking the test or reference drug.
The main investigator creates a table using randomization and divides 40 patients in 2 groups which only he knows the details of group. Test or reference drug is prepared base on its brochure, so patients are blinded regarding to the kind of drugs.
Patients are informed that they will be given the Iranian test drug or approved reference drug, although they are unaware of which drug is the test and which is the reference.
Test or reference is the same drug but produced with different manufacturers, so there is not any intervention in treatment.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-02-28, 1402/12/09
-
Ethics committee reference number
-
IR.TUMS.TIPS.REC.1402.174
Health conditions studied
1
-
Description of health condition studied
-
Triptorelin, Bioequivalent, Pharmacokinetics
-
ICD-10 code
-
C61
-
ICD-10 code description
-
Malignant neoplasm of prostate
Primary outcomes
1
-
Description
-
determination of drug concentration in blood serum
-
Timepoint
-
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
-
Method of measurement
-
Triptorelin ELISA Kit
Secondary outcomes
1
-
Description
-
Time to peak drug concentration
-
Timepoint
-
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
-
Method of measurement
-
observational
2
-
Description
-
Maximum drug concentration
-
Timepoint
-
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
-
Method of measurement
-
observational
3
-
Description
-
Area under the concentration–time curves
-
Timepoint
-
0, 1, 2, 3, 4, 6, 8, 12, 24 hours and 2, 3, 4, 7, 14, 21, 28 day after administration.
-
Method of measurement
-
linear trapezoidal method
Intervention groups
1
-
Description
-
Intervention group: Single dose administration of injectable sustained release formulations of Triptorelin (Decatrip®) in Patients with prostate cancer
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Intervention group: Single dose administration of injectable sustained release formulations of Triptorelin (Dipherelin®) in Patients with prostate cancer
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Pooyesh Darou Biopharmaceuticals company
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Industry
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
Only protocol and methods of study are shareable
-
When the data will become available and for how long
-
Starting access 6 months after publication of data
-
To whom data/document is available
-
Pharmaceutical and medical sciences researchers
-
Under which criteria data/document could be used
-
Using is not authorized
-
From where data/document is obtainable
-
contact with E-mail of the main researcher
-
What processes are involved for a request to access data/document
-
Personal and academic details and the aim of data request.
-
Comments
-