INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. MedDRA version: 9.1 Level: LLT Classification code 10008927 Term: Chronic interstitial cystitis
Conditions
Interventions
Product Name: PD 0299685
Pharmaceutical Form: Capsule, hard
CAS Number: 313651-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the pl
Sponsors
Pfizer Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Visit 1. The following inclusion criteria have to be met in order for a subject to be randomized into this trial: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male and female subjects aged =18 years. 3. Diagnosis of IC/PBS 4. Evidence of cystoscopy within 2 years of screening to confirm the absence of other significant lower urinary tract pathology and the presence or absence of cystoscopic features of IC (eg glomerulations, Hunner’s ulcer). Note: Cystoscopy is mandated within 2 years of enrollment. Subjects who have not had cystoscopy within 2 years of screening may undergo the procedure at screening. However placebo run-in would need to be deferred according to the type of cystoscopy performed. Subjects undergoing general anesthetic cystoscopy may be included at the discretion of the Pfizer study clinician, and any such case should be discussed prior to their enrollment. 5. Moderate to severe IC/PBS at screening (Visit 1) as defined by PUF and ICSI total scores: • PUF total score =13 with a score of 2 or greater on question 5 (pain) • ICSI total score =7 6. Female subjects must be non-pregnant and non-lactating, and be either, postmenopausal, surgically sterilized, or using an appropriate method of contraception. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (Visit 1). See Section 5.4 for further details. 7. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities. Visit 2. The following continuation criteria have to be met in order for subjects to be randomized: 8. Completes at least 4 daily pain scores during the 7 days prior to randomization with a mean daily worst pain severity score of =4 (0-10 NRS); the mean severity score is defined as the average of all 24 hr worst pain severity scores recorded in the 7 days prior to randomization. 9. Mean micturition frequency per 24 hours =8 as derived from the symptom diary completed prior to Visit 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Symptoms of IC =6 months prior to Screening 2. Post-void residual volume >200 mL at Screening 3. Mean voided volume 350 mL 4. Total volume voided >3000 mL per 24 hours 5. Greater than 1+ hematuria on dipstick at Screening, unless fully investigated prior to randomization. Subjects who are menstruating may be re-screened once menstruation has ceased 6. Proven UTI at Screening or randomization 7. Medical history at Screening •Any history of: Genitourinary tuberculosis, high grade/stage bladder cancer of any histological type, urethral cancer, prostate cancer; recurrent urinary tract infection defined as = 2 UTIs in past 6 months or = 3 in 1 year; lower urinary tract anatomical anomaly, urethral and/or bladder obstruction; pelvic radiotherapy. •=5 years Low grade/stage TCC •History within prior 3 months of: Bacterial prostatitis; urethritis; active genital herpes. •= 6 weeks Bacterial cystitis •Current history of: Proven genitourinary infection, symptomatic urinary tract stone. 8. Subjects who have undergone the following procedures: •Any history of: Augmentation cystoplasty, cystectomy or cystolysis, neurectomy •=6 months prior to screening: Urogenital surgery such as hysterectomy, urethral sling procedure, urinary incontinence surgery, trans-vaginal surgery, prolapse surgery, vaginal delivery or cesarean section, prostate surgery or treatment, other bladder or urethral surgery which could interfere with bladder function. •=3 months prior to screening: Formal therapeutic urethral dilatation or urethrotomy •=6 weeks prior to screening: Cystoscopy under general anesthetic, Hydrodistention, laser or electrofulguration of Hunner’s ulcer, prostate biopsy. •=2 weeks Cystoscopy under local anesthetic, bladder biopsy, urodynamics (cystometrogram) 9. The following conditions at Screening: Indwelling urinary catheters or who perform Intermittent Self Catheterization, Passive urinary incontinence, Incapable of independent toileting 10. Subjects at Screening who intend to start bladder training program, electrostimulation/neuromodulation, acupuncture, or physiotherapy during the study Subjects who are on an established regimen for =3 months prior to Screening may remain on this as long as it remains unchanged for the duration of the study 11. Subjects taking the following treatments for their interstitial cystitis at Screening as noted below: •Prior 6 months: Intravesical Botulinum toxin A or BCG •Prior 3 months: Biologic agents •Prior 1 month: Other intravesical treatments not otherwise specified, including butnot limited to dimethylsulfoxide, pentosan polysulphate, sodium hyaluronate,heparin, chondroitin sulfate, lidocaine or bupivicaine. •Prior 2 weeks: Oral gabapentin or pregabalin 12. Receipt of any investigational drug within 30 days (or 5 times the plasma half life, whichever is longer) preceding the Screening visit, or during the course of the study. Subjects who have received tanezumab in a previous study should wait at least 147 days from dosing until randomization in this study 13. History of allergic or hypersensitivity reaction to gabapentin, pregabalin, or PD 0299685 or ingredients of the formulations 14. Estimated Glomerular Filtration Rate (eGFR by Cockcroft-Gault) =60 mL/min at Screening 15. Clinically significant abnormal ECG at Screening including QTcF >500 msec 16. Clinically significant abnormalities on Screening laboratory tests 17. Suicide Behaviors Questionnaire – Revised score =8 at screening 18. Patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of PD 0299685 in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome including bladder pain, urinary urgency and frequency. ;Secondary Objective: To assess the safety and tolerability of PD 0299685.;Primary end point(s): Change from baseline to Week 12 in the worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). Change from baseline to Week 12 in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. | — |
Countries
Denmark, Finland, France, Germany
Outcome results
None listed