The study of selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor effect in patients with benign prostatic hyperplasia who are on alpha-blocker drugs and its association with PV, PVR, PSA, LUTS
In this study, we want to investigate and compare the effects of two drugs of Celecoxib and Naproxen on lower urinary tract symptoms, prostate specific antigen, prostate volume, and post void residual urinary volume in patients with moderate to severe prostate hyperplasia. These variables are evaluated at the beginning of the study and 3 months after the intervention. For evaluation of the effect of Celecoxib and Naproxen, three groups of 20 people are examined. To 20 patients, 200 mg of Celecoxib daily plus 400 micrograms of Tamsulosin daily is given, and 20 others receive 500 mg of Naproxen daily plus 400 g of Tamsulosin every day, and 20 others as the control group, receive only 400 mg of Tamsulosin daily.
Each group of 3 groups is given daily 20 mg Omeprazole for prevention of gastrointestinal disorders and for the homogenization of groups.
In this study, men over the age of 50 who have a moderate to severe benign prostatic hyperplasia with an international prostate symptom score of more than 8 and conditions in accordance with the specifications of research Can be enrolled.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017091836241N2
Registration date:2017-11-02, 1396/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-02, 1396/08/11
Registrant information
Name
Zahra Madadi
Name of organization / entity
Tehran university medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 3660 4854
Email address
z.madady@ncdrc.info
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor effect in patients with benign prostatic hyperplasia who are on alpha-blocker drugs and its association with PV, PVR, PSA, LUTS
Public title
Evaluation of the selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor in benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men over the age of 50 who have moderate to severe benign prostatic hyperplasia with international prostate symptoms score greater than 8; benign prostate diagnosis; no Liver problem; no active infections; no history of frequent urinary tract infections; no clear malignancy; no stone in the urethra, ureter and bladder; no history of urolithiasis; no prostate transurethral removal; no history of inflammation of the prostate; absence of a microscopy hematuria and advanced; no history of or retention; no history of trauma of the lower back and perineal and urethra; no history of cystoscopy; no history of sexually transmitted infections; no history of pelvic or urological surgery; non diabetic; non-neurological diseases (CNA, Parkinson's disease, MS and lumbar disks); history of congestive heart failure; no history of pelvic radiotherapy; no history of tuberculosis; no renal failure with creatinine higher than 1.3; no history of antidepressants, antihistamines, bronchodilators, diuretics and narcotics in the last 3 months; no history of psychological diseases (such as Schizopherenia, severe depression); lack of experience in the use of effective drugs in the treatment of benign prostatic hypertrophy in the last 3 months, including 5α-alpha-reductates and alpha-blockers, and phosphodiesterase inhibitors; no history of persistent alcohol and caffeine intake; high fluid intake; gastrointestinal ulcer or gastrointestinal bleeding.
Exclusion criteria: Patient disagreement; unwillingness to follow up the study program for any reason; sensitivity to the drug and its ingredients؛ the use of the drug causes patient dissatisfaction; the acute urinary problems so that the person has urinary retention and the condition is so severe that it requires catheterization and surgery; prostate cancer
Age
From 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Pharmaceutical Sciences Branch
Street address
Yakhchal Street, Gholhak, Shariati
City
Tehran
Postal code
19395-6466
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
IR.IUA.PS.REC.1395.35
Health conditions studied
1
Description of health condition studied
Benign prostate hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
International Prostate Symptom Score
Timepoint
Before intervention and 3 months after start of intervention
Method of measurement
questionnaire
2
Description
quality of life
Timepoint
Before intervention and 3 months after start of intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Prostate Specific Antigen
Timepoint
Before intervention and 3 months after start of intervention
Method of measurement
Blood test
2
Description
Prostate Volume
Timepoint
Before intervention and 3 months after start of intervention
Method of measurement
Abdominal ultrasound
3
Description
Post-Void Residual Urine Volume
Timepoint
Before intervention and 3 months after start of intervention
Method of measurement
Abdominal ultrasound
Intervention groups
1
Description
Intervention group 1: Capsule Tamsulosin 0.4 mg half an hour after meals once a day plus capsule Celecoxib 200 mg with food once a day plus capsule Omeprazole 20 mg half an hour before breakfast
Category
Treatment - Drugs
2
Description
Intervention group 2: Capsule Tamsulosin 0.4 mg half an hour after meals once a day plus Tablet Naproxen 500 mg with food once a day plus capsule Omeprazole 20 mg half an hour before breakfast
Category
Treatment - Drugs
3
Description
Control group: Capsule Tamsulosin 0.4 mg half an hour after meals once a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo-ali Hospital Tehran
Full name of responsible person
Zahra Madady
Street address
Damavand Avenue, Imam Hossein Square,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Azad University of Pharmaceutical Sciences
Full name of responsible person
Seyyed Jalaluddin Hosseini Ghonche
Street address
Yakhchal Street, Gholhak, Shariati
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Azad University of Pharmaceutical Sciences