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Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Urigen
Sponsor:
Information provided by (Responsible Party):
Urigen
ClinicalTrials.gov Identifier:
NCT02591199
First received: October 28, 2015
Last updated: June 15, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Interstitial Cystitis
Bladder Pain Syndrome
Drug: URG101
Drug: Placebo
Drug: Lidocaine
Drug: Heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Biphasic Adaptive Design 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

Resource links provided by NLM:


Further study details as provided by Urigen:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Change in urgency from baseline 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.


Estimated Enrollment: 348
Study Start Date: September 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: URG101
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.
Drug: URG101
Placebo Comparator: Placebo
A single 15 mL dose of placebo delivered to the bladder via catheter.
Drug: Placebo
Experimental: Lidocaine
A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.
Drug: Lidocaine
Experimental: Heparin
A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.
Drug: Heparin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02591199

Contacts
Contact: Kathy Grako, PhD 858-452-7271 ext 226 kgrako@cato.com
Contact: Amelie Rodrigue-Way, PhD 514-856-2286 ext 274 arodrigueway@cato.com

Locations
United States, California
IC Study, LLC Recruiting
Escondido, California, United States, 92025
University of California San Diego Recruiting
San Diego, California, United States, 92103
Scripps Clinic Recruiting
San Diego, California, United States, 92130
United States, Georgia
Georgia Urology Recruiting
Cartersville, Georgia, United States, 30120
United States, Kansas
The Urogynecology Center Recruiting
Overland Park, Kansas, United States, 66209
United States, New York
The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System Recruiting
Lake Success, New York, United States, 11042
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
MetroHealth System, Center for Advanced Gynecology Recruiting
Cleveland, Ohio, United States, 44109
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford Research Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Virginia
Urology of Virginia, PLLC Recruiting
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Urigen
Investigators
Study Chair: C. Lowell Parsons, MD Urigen
  More Information

Additional Information:
Responsible Party: Urigen
ClinicalTrials.gov Identifier: NCT02591199     History of Changes
Other Study ID Numbers: URG101-105
Study First Received: October 28, 2015
Last Updated: June 15, 2016

Additional relevant MeSH terms:
Syndrome
Cystitis
Somatoform Disorders
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Mental Disorders
Lidocaine
Calcium heparin
Heparin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on April 24, 2017