CTRI/2022/01/039475招募中4 期
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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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