| CTRI Number |
CTRI/2022/01/039475 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
26/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Active PMS in BPH |
|
Scientific Title of Study
|
Active Post Marketing Surveillance of FDC containing Silodosin 8 mg and Dutasteride 0.5 mg (Prostagard-D 8) in patients with mild to moderate BPH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLI/PRO/010, Version Number: 1.0 Dated: 26 Nov 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinayak Sargar |
| Designation |
Assistant Manager- Medical Affairs & Pharmacovigilance |
| Affiliation |
Optimus Pharma Pvt. Ltd. |
| Address |
2nd Floor, Sy No.37A & 37P, Plot No. 6P, Signature Towers, Kothaguda, Kondapur,
Telangana-500084, INDIA
Hyderabad
TELANGANA
500084
India |
| Phone |
8007207400 |
| Fax |
|
| Email |
vinayak@optimuspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Rajarshi |
| Designation |
Head Regulatory |
| Affiliation |
ClinVigilant Research Private Limited |
| Address |
B2 309, Palladium, Opp. Vodafone Tower, Corporate Road, Prahladnagar,
Ahmedabad, Gujarat, 380051
Ahmadabad
GUJARAT
380051
India |
| Phone |
9820315688 |
| Fax |
|
| Email |
regulatory@clinvigilant.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinayak Sargar |
| Designation |
Assistant Manager- Medical Affairs & Pharmacovigilance |
| Affiliation |
Optimus Pharma Pvt. Ltd. |
| Address |
2nd Floor, Sy No.37A & 37P, Plot No. 6P, Signature Towers, Kothaguda, Kondapur,
Hyderabad
TELANGANA
500084
India |
| Phone |
8007207400 |
| Fax |
|
| Email |
vinayak@optimuspharma.com |
|
|
Source of Monetary or Material Support
|
| Optimus Pharma Pvt. Ltd.
2nd Floor, Sy No.37/A & 37/P, Plot No. 6P,
Signature Towers, Kothaguda, Kondapur,
Telangana-500084, INDIA
|
|
|
Primary Sponsor
|
| Name |
Optimus Pharma Pvt Ltd |
| Address |
2nd Floor, Sy No.37/A & 37/P, Plot No. 6P, Signature Towers, Kothaguda, Kondapur, Telangana-500084, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhil Gupta |
Cliniton Multi Speciality Clinic, |
Urology Department Room No 03, Malviya nagar, Jaipur: 302017
Jaipur
RAJASTHAN |
9106756273
clinops@clinvigilant.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| ACH Ethics Committee |
Approved |
| ETHICS COMMITTEE BRIJ MOHAN MEDICAL CENTER |
Approved |
| Ethics Committee of HB Specialty Hospital |
Approved |
| KALYANI Kidney Care Centre- Ethics Committee |
Approved |
| KIDS ETHICS COMMITTEE |
Approved |
| MUKTAI HOSPITAL INSTITUTIONAL REVIEW BOARD |
Approved |
| Shrey Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination of
Silodosin 8 mg and Dutasteride
0.5 mg tablet in Capsule |
One capsule taken orally daily
with a meal for 84 days (12
weeks). |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Adult male confirmed BPH patients with radiological examination and estimated PSA levels at least six months before enrollment
2. All patients aged 45-80 years giving informed consent to participate in the study.
3. Patients with IPSS < 19 due to BPH without any absolute indication for surgery.
4. Patients with enlarged prostate gland less than or equal to 30gm on either clinical examination or ultrasound Assessment (as available)
5. Patients with previously diagnosed BPH receiving Silodosin 8 mg and / or Dutasteride 0.5 mg as monotherapy or combination therapy as two individual tablets (to be substituted with the FDC)
6. Confirmed BPH patients with documented urine flow results available at screening not less than 10mL/Sec.
7. Patients willing to give informed consent for the study and willing to comply with all the study procedure and requirements.
|
|
| ExclusionCriteria |
| Details |
1. Unconfirmed and suspected cases of BPH
2. Confirmed cases of BPH with IPSS severity score 20 and above
3. Current severe urinary tract infections
4. Known allergy or contraindications to Silodosin and Dutasteride
5. History of syncope, and orthostatic hypotension
6. Bladder outlet obstruction due to cancer, calculi or stricture
7. Previous Transurethral Resection of the Prostate (TURP),
8. Any neurological disorders affecting storage and voiding functions, Prostatitis, PSA greater than 2.5 or higher in preceding 6 months
9. An episode of acute urinary retention within 4 weeks of study initiation,
10. Documented urinary tract infection,
11. Poorly controlled diabetes mellitus,
12. Poorly controlled hypertension.
13. Patients with mental disorders or illness who cannot understand or comply with the study protocol.
14. BPH with complications like CRF, hydronephrosis, acute bacterial prostatitis, hematuria.
15. Patients with LUTS and or bladder outlet obstruction due to causes other than BPH.
16. Patients taking nitrates for CYP3A4 inhibitors (ketoconazole, ritonavir) and CYP3A4 inducers (rifampicin).
17. Patients with previous history of prostate surgery, diagnosed cancer prostate.
18. Patients with severe cardiac, hepatic or renal insufficiency.
19. Patients with active untreated UTI, urolithiasis, PVR >200mls, patients in whom cystoscopy or biopsy has been done from urinary tract in the past 2 weeks urethral stricture disease, neurogenic bladder, prostate or urethral surgery, any previous history of continuous intermittent catheterization, h/o postural hypotension, patients with uncontrolled severe hypertension.
20. H/O treatment with verapamil, androgens, anti-androgens, diuretics, cholinergic, anticholinergics, phytotherapy in the past 3 months,
21. H/Oalcohol abuse, malignancy.
22. Patients with h/o any conditions exposing them to increased risk of adverse effects of silodosin including any serious life threatening cardiovascular, renal, neurological, hepatic. Any other disease or condition and any other systemic illness or disorder which in the clinical judgement
23. Patients who have participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in Urine Peak Flow Rate (Qmax)
2. Reduction in bother based on the International prostrate Symptom Score (IPSS)
3. BPH impact Index self-assessment questionnaire on urinary problems (patient self-assessment questionnaire)
4. Improvement in QoL (questionnaire) (IPSS question on QoL) |
Day 0 (Visit 1), Day 30± 5 days (Visit 2), Day 60± 5 (Visit 3), Day 90± 5 days (Visit 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Tolerance to the treatment and safety (assessment of adverse events and laboratory investigations)
2. Compliance to the treatment (patient rating) |
Day 0 (Visit 1), Day 30± 5 days (Visit 2), Day 60± 5 (Visit 3), Day 90± 5 days (Visit 4) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An active post-marketing surveillance study is proposed in this study to evaluate the safety and efficacy of this FDC in BPH patients. Silodosin is a highly selective α1A-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Oral silodosin has a rapid onset of effect in men with lower urinary tract symptoms (LUTS) associated with BPH, with improvements seen in voiding and storage symptoms, maximum urinary flow rate and health-related quality of life in well-designed, 12-week trials. Silodosin is generally well tolerated and is a useful option for the treatment of LUTS associated with BPH. The silodosin dose recommended by the FDA is 8 mg orally once a day. Dutasteride is an oral synthetic 4-azasteroid, is a potent, selective, irreversible inhibitor of type 1 and type 2 5alpha-reductase (5AR), the enzyme that converts testosterone to dihydrotestosterone (DHT) intracellularly. Oral dutasteride 0.5 mg once daily is approved for the treatment of moderate to severe symptomatic BPH in men with an enlarged prostate to improve symptoms, and to reduce the risk of acute urinary retention (AUR) and the need for BPH-related surgery. The good efficacy and tolerability of dutasteride maintained for up to 4 years in open-label extension studies is well- reported. |