Health Condition 1: null- Interstitial Cystitis/Bladder Pain Syndrome
Conditions
Interventions
Intervention1: Pentosan Polysulfate Sodium: Oral Capsule 100 mg of Watson Pharma Pvt. Ltd., India. 176 patients out of 528 will receive intervention drug. Each patients (176) will receive one capsule
Sponsors
Watson Pharma Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged more than 18 years with moderate to severe interstitial cystitis 2. Patient has experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least the previous 6 months prior to entry into the study. 3. An average voided bladder volume of 50 to 200 mL (as determined over 3 consecutive days documented in the urinary frequency diary). 4. Urine culture negative for clinically significant urinary tract infection (at baseline or within 2 weeks prior to baseline visit). 5. Urine cytology negative for neoplastic cells (at baseline or within 2 months prior to baseline visit). 6. Cystoscopic examination under anesthesia by the investigator showing petechial hemorrhages or ulcers following one or two distentions of the bladder at 80 cm of water pressure for one minute performed within 6 months prior to baseline visit and at least 6 weeks prior to baseline visit. Patients that enter remission after their cystoscopic examination should not be scheduled for their baseline visit until the symptoms reappear. 7. Patients currently being treated with Pentosan Polysulfate Sodium may be enrolled in the study if Pentosan Polysulfate Sodium treatment is stopped at least for 4 weeks (wash-out period) prior to baseline visit.
Exclusion criteria
Exclusion criteria: 1. More than 25 voids per day 2. Bladder capacity of more than 350 mL during awake exam 3. Patient is planning to use intravesical therapy for interstitial cystitis within one month prior to baseline visit. 4. Patient planning to use medical treatment for interstitial cystitis within one month prior to baseline visit. 5. Patient taking any anticoagulants 6. Patient with known aneurysm, thrombocytopenia, hemorrhagic disease, hemophilia, or gastrointestinal ulceration (e.g., active bleeding peptic ulcer disease), polyps, or diverticula. 7. Patient with known hypersensitivity to Pentosan Polysulfate Sodium, including excipients (microcrystalline cellulose and magnesium stearate), or heparin. 8. Patient who has a history of, or currently has, any of these: Neurogenic bladder or diabetic cystopathy, Pelvic irradiation or chemical cystitis, including that due to cyclophosphamide, Presence of urethral, pelvic, or rectal carcinoma, Benign or malignant bladder tumors, Tuberculous cystitis, Urinary schistosomiasis, Bladder or ureteral calculi, Active genital herpes within 3 months prior to study entry, Urethral and/or bladder obstruction, Augmentation cystoplasty, cystectomy, cystolysis, neurectomy or implanted peripheral nerve stimulator that has affected bladder function. 9. Patient has microscopic hematuria as defined as 5 RBC/high power field at baseline visit without a negative workup within the last year. 10. Patient has current chronic pain condition 11. Patient has clinically significant hepatic disease or clinically significant abnormal liver function tests. Gender specific exclusion criteria: Male: 1) Patient has a post-void residual volume of 150 cc by ultrasound. 2) Patient had a Trans Urethral Resection of Prostate (TURP), Trans Urethral Incision of Prostate (TUIP), Trans Urethral Incision of Bladder Neck (TUIBN), Trans Urethral Microwave Thermotherapy (TUMT), Trans Urethral Needle Ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy. 3) Patient has a history of prostate cancer. 4) Patient is currently being treated for chronic bacterial prostatitis. Female: 1) Patient has a positive pregnancy test at the baseline visit, is pregnant or lactating, or is planning to become pregnant during the study period. 2) Patient has a history of uterine, cervical or vaginal cancer during the past 3 years. 3) Patient has clinically significant vaginitis at baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the therapeutic equivalence of the efficacy and safety of Pentosan Polysulfate Sodium, Oral Capsule 100 mg (Watson Pharma Pvt. Ltd) and Elmiron Oral Capsule 100 mg (Orthoâ??McNeilâ??Janssen Pharmaceuticals, Inc) in the treatment of interstitial cystitis/bladder pain syndrome and Timepoint: Patient participation will last for 91 days (90 days of double-blind study treatment). Clinical Evaluations will be performed at: Visit 1: Pre-screening (Day-3) Visit 2: Baseline / Randomization Visit (Day 1) Visit 3: First Interim Visit (Day 15 ± 4 Days) Visit 4: Second Interim Visit (Day 30 ± 4 Days) Visit 5: Third Interim Visit (Day 60 ± 4 Days) Visit 6: End of Treatment Visit (Day 90 ± 4 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the superiority of the efficacy of Pentosan Polysulfate Sodium, OralTimepoint: Patient participation will last for 91 days (90 days of double-blind study treatment). Clinical Evaluations will be performed at: Visit 1: Pre-screening (Day-3) Visit 2: Baseline / Randomization Visit (Day 1) Visit 3: First Interim Visit (Day 15 ± 4 Days) Visit 4: Second Interim Visit (Day 30 ± 4 Days) Visit 5: Third Interim Visit (Day 60 ± 4 Days) Visit 6: End of Treatment Visit (Day 90 ± 4 Days) | — |
Countries
India
Contacts
Public ContactDr Sumit Arora
Lotus Labs Pvt Ltd
Outcome results
None listed