Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cys… (NCT02591199) | Clinical Trial Compass
TerminatedPhase 2
Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Stopped: Prematurely terminated due to data inconsistent with the experimental plan and lack of funding
United States91 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have provided written informed consent to participate in this trial
✓. Be male or female, ≥ 18 years of age
✓. Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
✓. 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
✓. Have a score of ≥ 15 and \< 30 on the PUF questionnaire, completed at screening
✓. A minimum score of 5 is required on the VAS
✓. Have been using a stable dose of hormone therapy for ≥ 3 months, if female and currently taking hormone therapy
Exclusion criteria
✕. 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.
✕
What they're measuring
1
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
Timeframe: 12 hours
2
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
. Have a known hypersensitivity to heparin or lidocaine
✕. 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
✕. 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.
✕. Have used any pain medication within 6 hours prior to study drug administration
✕. 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.
✕. 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
✕. Have a known clinically significant abnormal laboratory test value defined by the investigator