Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Brief summary
The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received.
Detailed description
This is a Phase 2a, randomized, double-blind, placebo controlled, multicenter, single-dose, pharmacokinetic study designed to determine the efficacy and safety of the combination product (URG101) compared with its individual components (Heparin Sodium and Lidocaine Hydrochloride). Eligible subjects exhibiting moderate to severe symptoms of bladder pain associated with their diagnosis of interstitial cystitis/bladder pain syndrome who have signed informed consent, will be screened and provisionally enrolled for intravesical treatment. On the day of study drug administration subjects will be randomized (2:1:2:1; URG101:placebo:lidocaine:heparin) and will receive a single administration of one of four intravesical treatments in a blinded fashion, based on random assignment: 1. URG101 (buffered lidocaine-heparin) 2. Placebo (phosphate buffer) 3. Lidocaine hydrocholoride buffered alone 4. Heparin sodium buffered alone Efficacy and safety assessments will be completed for 24 hours after study drug administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after study drug administration.
Interventions
Sponsors
Urigen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects diagnosed with interstitial cystitis/bladder pain syndrome must meet all of the following criteria to participate in the study: 1. Have provided written informed consent to participate in this trial 2. Be male or female, ≥ 18 years of age 3. Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study 4. May or may not have received a cystoscopy in association with their diagnosis of interstitial cystitis/bladder pain syndrome prior to or at time of screening 5. Have a score of ≥ 15 and \< 30 on the PUF questionnaire, completed at screening 6. A minimum score of 5 is required on the VAS 7. Have been using a stable dose of hormone therapy for ≥ 3 months, if female and currently taking hormone therapy
Exclusion criteria
1. Pregnant or breastfeeding. For females of child bearing potential and males, if sexually active, must be willing to commit to an acceptable method of birth control for the duration of the study. 2. Have a known hypersensitivity to heparin or lidocaine 3. Have used any local anesthetic by any route within 24 hours prior to study drug administration, or used a lidocaine patch within 14 days prior to study drug administration 4. Have used a tricyclic antidepressant or a gamma-Aminobutyric acid (GABA) analogue (gabapentin or pregabalin) unless taking the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day. 5. Have used any pain medication within 6 hours prior to study drug administration 6. Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry (generic names: fentanyl, hydrocodone, hydromorphone, levorphanol, medical marijuana, methadone, morphine, oxycodone, propoxyphene, tramadol). Subjects who have received codeine within this time period may be admitted if the use is not chronic, and not within 6 hours of enrollment, such that they are not at risk for GI or opiate withdrawal symptoms that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results. 7. Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results 8. Have a known clinically significant abnormal laboratory test value defined by the investigator 9. Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage) 10. Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain 11. Have severe depression, bipolar disorder, schizophrenia, anxiety, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder 12. Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results 13. Had bladder instillation therapy within 7 days prior to study entry or had a prior bladder instillation with heparin and lidocaine and did not respond 14. Had dilatation (hydrodistention) of bladder within 3 months of study entry 15. Evidence or suspected presence of cancer detected during cystoscopy prior to or at time of initial screening. 16. Has received any investigational drug or device within 30 days prior to screening 17. Is currently enrolled in another investigational drug or device study 18. Is unwilling or unable to abide by the requirements of the study 19. Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization 20. Have had any of the following: bacterial, chemical (including ketamine and cyclophosphamide) or radiation cystitis; gynecological, urological or rectal cancer; current chemotherapy; tuberculous cystitis; urinary schistosomiasis; bladder or uretal calculi; vaginitis or genital herpes; urethral diverticulum or bladder fistulae.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity | 12 hours | A calculation of average bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12). A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The average SPID-12 is calculated by multiplying the Pain Intensity Difference score at each time point by the duration since the preceding time point and then summing these values over the specific time period. A lower, negative average SPID-12 difference is better and indicates a reduction in pain intensity compared to the baseline score, whereas a positive score indicates an increase in pain intensity compared to baseline. The full range of results of the average SPID-12 difference could be -119 to +59. |
| Change of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity | 12 hours | A calculation of bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12) after administration of URG101 compared with the SPID-12 after administration of lidocaine alone, heparin alone, and placebo. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. A negative value indicates lower SPID-12 values for URG101. The full range of results of the average SPID-12 difference could be -119 to +59. |
Countries
United States
Contacts
STUDY_CHAIRC. Lowell Parsons, MD
Urigen
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 15.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 15 | 0 / 29 | 0 / 16 |
| other Total, other adverse events | 3 / 31 | 1 / 15 | 5 / 29 | 3 / 16 |
| serious Total, serious adverse events | 0 / 31 | 0 / 15 | 0 / 29 | 0 / 16 |
Outcome results
None listed