Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT02591199|
Recruitment Status : Terminated (Prematurely terminated based on interim study analysis)
First Posted : October 29, 2015
Last Update Posted : August 26, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Bladder Pain Syndrome||Drug: URG101 Drug: Placebo Drug: Lidocaine Drug: Heparin||Phase 2|
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:
- URG101 (buffered lidocaine-heparin)
- Placebo (phosphate buffer)
- Lidocaine hydrocholoride buffered alone
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 14, 2018|
|Actual Study Completion Date :||June 18, 2018|
A single 15 mL dose of URG101,a mix of buffered Lidocaine (200 mg) and Heparin (50,000 IU), delivered to the bladder via catheter.
Placebo Comparator: Placebo
A single 15 mL dose of placebo delivered to the bladder via catheter.
A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.
A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.
- Change in bladder pain differences from baseline as determined by using the Visual Analog Scale (VAS) [ Time Frame: 24 hours ]The primary objective is to evaluate the change in bladder pain intensity differences from baseline to either 12 hours or 24 hours after administration of URG101 compared with the administration of lidocaine alone, heparin alone, and placebo as determined by using the Visual Analog Scale (VAS).
- Change in urgency from baseline as determined using the VAS [ Time Frame: 24 hours ]Evaluate the change in urgency intensity differences from baseline to 12 or 24 hours after administration of URG101 compared to lidocaine alone, heparin alone, and placebo using the VAS.
- The relationship of plasma lidocaine concentrations at 1 hour after study drug administration to bladder pain and urgency [ Time Frame: 24 hours ]Evaluate the relationship of plasma lidocaine concentrations at 1 hour after study drug administration to bladder pain and urgency at 1 hour, and from baseline to 12 and 24 hours after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.
- Safety and tolerability of study medication (Adverse events) [ Time Frame: Up to 72 hours ]Adverse events reported after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Subjects diagnosed with interstitial cystitis/bladder pain syndrome must meet all of the following criteria to participate in the study:
- 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
- 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.
- 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
- 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)
- 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
- Have severe depression, bipolar disorder, schizophrenia, anxiety, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
- 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
- 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
- Had dilatation (hydrodistention) of bladder within 3 months of study entry
- Evidence or suspected presence of cancer detected during cystoscopy prior to or at time of initial screening.
- Has received any investigational drug or device within 30 days prior to screening
- Is currently enrolled in another investigational drug or device study
- Is unwilling or unable to abide by the requirements of the study
- Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591199
|United States, California|
|IC Study, LLC|
|Escondido, California, United States, 92025|
|University of California San Diego|
|San Diego, California, United States, 92103|
|United States, Georgia|
|Cartersville, Georgia, United States, 30120|
|United States, Kansas|
|The Urogynecology Center|
|Overland Park, Kansas, United States, 66209|
|United States, New Jersey|
|Rutgers Women's Health Clinic|
|New Brunswick, New Jersey, United States, 08901|
|United States, New York|
|The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System|
|Lake Success, New York, United States, 11042|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|MetroHealth System, Center for Advanced Gynecology|
|Cleveland, Ohio, United States, 44109|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57105|
|United States, Virginia|
|Urology of Virginia, PLLC|
|Virginia Beach, Virginia, United States, 23462|
|Study Chair:||C. Lowell Parsons, MD||Urigen|
|Other Study ID Numbers:||
|First Posted:||October 29, 2015 Key Record Dates|
|Last Update Posted:||August 26, 2020|
|Last Verified:||August 2020|
Urinary Bladder Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Fibrin Modulating Agents