Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

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

Details

This is a biphasic adaptive design phase 2a, prospective, randomized, double-blind, placebo controlled, multicenter, single-dose, pharmacokinetic study designed to determine the efficacy and safety of the combination product (URG101) with its individual components (Heparin Sodium and Lidocaine Hydrochloride). The study will consist of a run-in phase of 48 subjects and an investigational phase of up to 300 subjects.

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
  3. Lidocaine Hydrocholoride buffered alone
  4. Heparin Sodium buffered alone

The study is 24 hours in duration.

Keywords

Interstitial Cystitis Bladder Pain Syndrome Syndrome Somatoform Disorders Cystitis Cystitis, Interstitial Lidocaine Calcium heparin Heparin URG101

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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 unless taking the medication for ≥ 3 months or Neurontin® within 21 days prior to receiving study drug
  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: codeine, fentanyl, hydrocodone, hydromorphone, levorphanol, medical marijuana,methadone, morphine, oxycodone, propoxyphene, tramadol)
  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.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • Scripps Clinic accepting new patients
    San Diego California 92130 United States
  • IC Study, LLC accepting new patients
    Escondido California 92025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Urigen
Links
Urigen N.A., Inc. homepage
Engage-24 Clinical Trial Homepage
ID
NCT02591199
Phase
Phase 2
Study Type
Interventional
Last Updated
May 1, 2018