Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02591199
• Other study ID #: URG101-105
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: June 18, 2018

Study information

• Verified date: August 2020
• Source: Urigen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: June 18, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• URG101

• Placebo

• Lidocaine

• Heparin

Locations

Country	Name	City	State
United States	Georgia Urology	Cartersville	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	MetroHealth System, Center for Advanced Gynecology	Cleveland	Ohio
United States	IC Study, LLC	Escondido	California
United States	The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System	Lake Success	New York
United States	Rutgers Women's Health Clinic	New Brunswick	New Jersey
United States	The Urogynecology Center	Overland Park	Kansas
United States	University of California San Diego	San Diego	California
United States	Sanford Research	Sioux Falls	South Dakota
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Urigen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bladder pain differences from baseline as determined by using the Visual Analog Scale (VAS)	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).	24 hours
Secondary	Change in urgency from baseline as determined using the VAS	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.	24 hours
Secondary	The relationship of plasma lidocaine concentrations at 1 hour after study drug administration to bladder pain and urgency	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.	24 hours
Secondary	Safety and tolerability of study medication (Adverse events)	Adverse events reported after treatment with URG101 compared to lidocaine alone, heparin alone, and placebo.	Up to 72 hours

External Links

•   Urigen N.A., Inc. homepage