None listed
Conditions
Brief summary
GLX-100 is an investigational medical device containing glycosaminoglycan (GAG) designed to coat the inner lining of the bladder and is believed to reduce irritation and pain. The purpose of this research is to test the safety and tolerability of the device GLX-100 in participants with IC/PBS. This research will also evaluate whether GLX-100 can reduce the amount of pain and other symptoms associated with IC/PBS.
Interventions
A catheter will be inserted into the participant’s bladder through which GLX-100 solution (administered as a 40 mL instillation containing 2% polymer in saline) once a week for 8 weeks. The GLX-100 solution will be retained in the bladder for a minimum of 30 minutes, or as long as can be comfortably tolerated, before being voided.
Sponsors
Glycologix Australia PTY LTD
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Females aged 18 years or greater at the time of signing the informed consent form (ICF); 2. Diagnosis of interstitial cystitis (IC)/ bladder pain syndrome (BPS) according to American Urological Association (AUA) Guidelines 2022 with symptoms for 6 months or more prior to screening; 3. Visual analogue scale (VAS) bladder pain score of at least 4 (average pain during the last 3 days; scale 0 to 10) at Screening and Day 1 (prior to dosing); 4. Had a prior cystoscopy to rule out confounding conditions; 5. Been on unchanged acceptable oral medicines for IC/PBS for at least 3 months prior to Day 1; 6. Positive bladder permeability test during the screening period; 7. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first infusion and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must agree to use an acceptable form of contraception during the treatment period and for at least 8 weeks after the last instillation of the investigational medical device; • WOCBP are defined as any female who has experienced menarche and who have not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and are not postmenopausal. • Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. 8. Be capable of giving informed consent and reading and signing the ICF after the nature of the study has been fully explained by the investigator or investigator designee; 9. Be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.
Exclusion criteria
1. Known current Hunner’s lesions; 2. McGill catastrophizing pain score >30; 3. Received narcotics, oral immunosuppressives, pentosan polysulfate, tricyclic antidepressants (TCAs) (e.g., amitriptyline, pregabalin, or nortriptyline), or intravesical treatment for IC/PBS within 1 month, hydrodistension within 3 months, or intradetrusor Botulinum toxin (BOTOX) injections within 12 months prior Day 1; 4. Has untreated endometriosis; 5. Has recurrent urinary tract infection (UTI) (more than 3 UTIs over the last 12 months of the screening visit) or active UTI (positive bacterial urine culture) within 6 weeks prior to Day 1; 6. Have a history of a clinically significant allergic reaction or hypersensitivity, as judged by the investigator, to any drug or any component of the study drug formulations used in the study (see Investigator’s Brochure); 7. Active Coronavirus disease 2019 (COVID-19) infection within 2 weeks prior to Day 1; 8. Active substance abuse (drugs or alcohol), history of chronic substance abuse within the past year, or prior chronic substance abuse judged by the investigator to recur during the study;
Outcome results
None listed