Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000602628
Ethics application status
Approved
Date submitted
22/03/2023
Date registered
1/06/2023
Date last updated
24/04/2024
Date data sharing statement initially provided
1/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Preliminary Effectiveness of GLX-100 in Participants With Interstitial Cystitis/Painful Bladder Syndrome.
Scientific title
A Phase 1b, Open-label, Single-Arm Study Evaluating the Safety and Efficacy of GLX-100 in Adults with Interstitial Cystitis/Painful Bladder Syndrome.
Secondary ID [1] 309048 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Cystitis 329103 0
Painful Bladder Syndrome 329104 0
Condition category
Condition code
Renal and Urogenital 326078 326078 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325490 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333947 0
Safety and tolerability of GLX-100 by measuring the incidence and severity of adverse events. Examples for possible adverse events include urinary tract infections and urinary urgency that will be assessed according to standard clinical practice. Medical notes will be used to collect adverse event data.
Timepoint [1] 333947 0
16 weeks post initial instillation.
Secondary outcome [1] 418815 0
Differences in symptoms as measured by Visual Analog Scale
Timepoint [1] 418815 0
16 weeks post initial instillation.
Secondary outcome [2] 422199 0
Response to treatment as reflected by a change in baseline measured using Global response scale assessment
Timepoint [2] 422199 0
16 weeks post initial instillation
Secondary outcome [3] 422200 0
Change in symptoms as reflected by a change in baseline measured using using Oleary-Sant questionnaire.
Timepoint [3] 422200 0
16 weeks post initial instillation
Secondary outcome [4] 422201 0
Change in urinary frequency as reflected by a change in baseline measured using a 24hr urine frequency diary.
Timepoint [4] 422201 0
16 weeks post initial instillation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
17/10/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 26476 0
St George Hospital - Kogarah
Recruitment hospital [2] 26477 0
Westmead Hospital - Westmead
Recruitment hospital [3] 26478 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 42462 0
2145 - Westmead
Recruitment postcode(s) [2] 42468 0
2217 - Kogarah
Recruitment postcode(s) [3] 42466 0
2302 - Newcastle West
Recruitment postcode(s) [4] 42463 0
2303 - Hamilton East
Recruitment postcode(s) [5] 42467 0
3165 - Bentleigh East
Recruitment postcode(s) [6] 42464 0
4120 - Greenslopes
Recruitment postcode(s) [7] 42465 0
4217 - Benowa

Funding & Sponsors
Funding source category [1] 313251 0
Commercial sector/Industry
Name [1] 313251 0
Glycologix Australia PTY LTD
Country [1] 313251 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Glycologix Australia PTY LTD
Address
Glycologix Australia PTY LTD
40 City Road
SOUTHBANK
Victoria , 3006
Australia
Country
Australia
Secondary sponsor category [1] 314990 0
None
Name [1] 314990 0
Address [1] 314990 0
Country [1] 314990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312484 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 312484 0
Research Support Services Level 2
I Block, Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 312484 0
Australia
Date submitted for ethics approval [1] 312484 0
18/01/2023
Approval date [1] 312484 0
22/05/2023
Ethics approval number [1] 312484 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124822 0
Prof Anna Rosamilia
Address 124822 0
Moorabbin Hospital
823-865 Centre Road
East Bentleigh
VIC 3165

Country 124822 0
Australia
Phone 124822 0
+61 3 9928 8588
Fax 124822 0
Email 124822 0
Anna.Rosamilia@monashhealth.org
Contact person for public queries
Name 124823 0
Ms Alison Leitch
Address 124823 0
Moorabbin Hospital
823-865 Centre Road
East Bentleigh
VIC 3165
Country 124823 0
Australia
Phone 124823 0
+61 3 9928 8588
Fax 124823 0
Email 124823 0
Alison.Macaluso@monashhealth.org
Contact person for scientific queries
Name 124824 0
Ms Alison Leitch
Address 124824 0
Moorabbin Hospital
823-865 Centre Road
East Bentleigh
VIC 3165
Country 124824 0
Australia
Phone 124824 0
+61 3 9928 8588
Fax 124824 0
Email 124824 0
Alison.Macaluso@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.