Study to evaluate the safety, absorption and elimination in the urine of a new diclofenac-based drug administered directly into the bladder
| ISRCTN | ISRCTN42997318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42997318 |
| Sponsor's internal code | 24CH-HyDi06 |
| Sponsor | IBSA Institut Biochimique (Switzerland) |
| Funder | IBSA Institut Biochimique |
- Submission date
- 19/01/2026
- Registration date
- 21/01/2026
- Last edited
- 23/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The Sponsor, IBSA Institut Biochimique S.A., is investigating the safety, tolerability and pharmacokinetics (how the body affects the drug) of a new formulation of diclofenac sodium mixed with a diluent solution which will be instilled into the bladder of healthy women and women affected by recurrent urinary tract infections (UTIs) for the first time. The hypothesis is that, after the intravesical instillation, diclofenac can support the reduction of acute UTI episodes in patients affected by recurrent UTIs.
Who can participate?
Part A: healthy women aged 18-55 years
Part B: women with recurrent urinary tract infections (in remission) aged 18-55 years
What does the study involve?
Part A of the study:
The study will involve three consecutive groups (cohorts) of 8 healthy women. Each participant will receive either the investigational treatment or a sham control (saline solution), assigned at random.
Cohort 1: 1 ml of diclofenac (an anti‑inflammatory drug) + 45 ml of a diluent solution, or 46 ml of saline solution (sham control).
Cohort 2: 2 ml of diclofenac + 45 ml of solution, or 47 ml of saline solution.
Cohort 3: 3 ml of diclofenac + 45 ml of solution, or 48 ml of saline solution.
At first, only one participant in each cohort will receive the investigational drug, while another will receive the sham control. The following day, the medical team will assess whether the treatment is safe before proceeding with the remaining 6 participants (5 will receive the drug and 1 the sham control).
After each cohort, the study investigator will review any side effects and decide whether to move on to the next dose level. The study sponsor must approve each progression. Safety rules are in place to stop the study if necessary.
Part B of the study:
The safest dose identified in Part A will be tested in 6 women with recurrent urinary tract infections (without any active infection ongoing).
In both parts of the study, the drug will be administered on Day 1 at 08:00 (±1 hour), on an empty stomach. The physician will introduce the solution into the participants’ bladder using a catheter.
What are the possible benefits and risks of participating?
No potential benefits are foreseen for the subjects participating in this study. However, a possible clinical benefit of this clinical study is to provide patients suffering from recurrent urinary tract infections with a potentially effective alternative to antibiotic treatment. The product under evaluation contains the widely used and well-known active ingredient diclofenac, which has an established favourable benefit-risk profile. Minimal risks are anticipated regarding tolerability at the instillation site.
Where is the study run from?
The study was conducted at the CROSS Research S.A. Phase I Unit Clinical Centre, in Arzo (Switzerland)
When is the study starting and how long is it expected to run for?
October 2025 to October 2026
Who is funding the study?
IBSA Institut Biochimique S.A. (Switzerland)
Who is the main contact?
Dr Milko Radicioni, clinic@croalliance.com
Contact information
Scientific, Public
Via Pian Scairolo, 49
Pazzallo
6912
Switzerland
 ORCID ID |
0000-0003-0465-8953 |
|---|---|
| Phone | +41 (0)58 36 01 735 |
| valeria.frangione@ibsa.ch |
Principal investigator, Scientific
Via F.A. Giorgioli, 14
Arzo
6864
Switzerland
| ORCID ID |
0000-0002-3940-8375 |
|---|---|
| Phone | +41 (0)91 64 04 450 |
| milko.radicioni@croalliance.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Single |
| Purpose | Basic science, Prevention, Treatment |
| Scientific title | Safety and pharmacokinetic study of a new diclofenac formulation administered to women by intravesical instillation Single centre, two parts, safety, tolerability and pharmacokinetic study; Part A: randomized, single-blind, sham-controlled, single ascending dose study in healthy women; Part B: open-label, single-dose study in women affected by recurrent urinary tract infections |
| Study objectives | Part A: The primary objective of Part A is to evaluate the safety and tolerability of three single ascending doses (1, 2 and 3 mL) of Diclofenac sodium 75 mg/mL solution in a diluent solution versus sham control, after intravesical administration to healthy women. The secondary objective of study Part A is to evaluate the pharmacokinetic profile and parameters of diclofenac in plasma and urine after IMP administrations of 3 single ascending doses (1, 2 and 3 mL) of Diclofenac sodium 75 mg/mL solution in a diluent solution after intravesical administration to healthy women. Part B: The primary objective of study Part B is to evaluate the safety and tolerability of the highest dose of Diclofenac sodium 75 mg/mL solution in a diluent solution, considered as safe in study Part A, after intravesical administration to women with recurrent urinary tract infections in the quiescent phase. The secondary objective of study Part B is to evaluate the pharmacokinetic profile and parameters of diclofenac in plasma and urine after intravesical administration of the highest safe dose (1, 2 or 3 mL) of Diclofenac sodium 75 mg/mL solution in a diluent solution after intravesical administration to women with recurrent urinary tract infections in the quiescent phase. |
| Ethics approval(s) |
Approved 29/07/2025, Cantonal Ethics Committee (c/o Ufficio di sanità, Via Orico 5, Bellinzona, 6501, Switzerland; +41 (0)91 814 30 57; dss-ce@ti.ch), ref: 2025-00808; Rif. CE 4840 |
| Health condition(s) or problem(s) studied | Urinary tract infections (UTIs) |
| Intervention | The study is divided into two parts: Part A: Healthy volunteers will receive a single dose of the investigational drug (at different concentrations: D1, D2, or D3) or a sham control, in a random order. The study will involve three consecutive groups (cohorts) of 8 healthy women. Cohort 1: 1 ml of diclofenac (an anti‑inflammatory drug) + 45 ml of a diluent solution, or 46 ml of saline solution (sham control). Cohort 2: 2 ml of diclofenac + 45 ml of solution, or 47 ml of saline solution. Cohort 3: 3 ml of diclofenac + 45 ml of solution, or 48 ml of saline solution. At first, only one participant in each cohort will receive the investigational drug, while another will receive the sham control. The following day, the medical team will assess whether the treatment is safe before proceeding with the remaining 6 participants (5 will receive the drug and 1 the sham control). After each cohort, the study investigator will review any side effects and decide whether to move on to the next dose level. The study sponsor must approve each progression. Safety rules are in place to stop the study if necessary. Part B: Participants with recurrent urinary tract infections will receive an administration of the highest safe dose identified in Part A. In both parts, the drug or sham control will be administered directly into the bladder through a urinary catheter on Day 1 at 08:00 (± 1 hour), and on an empty stomach. Administration procedure: Before instillation, the participant must urinate to completely empty the bladder. The investigational drug will be prepared by mixing a diclofenac solution with a diluent, while the sham control will consist of sterile saline solution. Preparation will take place in a separate room outside the participant's view (to maintain the study blind). After aseptic cleaning, the physician will instil the solution into the bladder using a urinary catheter while the participant is lying down. After instillation, the participant must hold the urine for about 1 hour before emptying the bladder again. To ensure that participants cannot guess which treatment they are receiving, a cover will be placed over their knees, as the color and consistency of the drug may differ from the sham control. Safety measures: The entire procedure will be performed using sterile gloves to avoid contamination. The administration time and the time of the first urination after treatment will be recorded in the study documents. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Diclofenac |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Signed written informed consent before inclusion in the study. 2. Healthy women (Part A) or women with recurrent urinary tract infections (Part B), 18-55 years old inclusive 3. BMI: 18.5-30 kg/m2 inclusive 4. systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position 5. ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study 6. Contraception and fertility: women of child-bearing potential must be using at least one of the following reliable methods of contraception 6.1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 6.2. A non-hormonal intrauterine device (IUD) or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 6.3. A male sexual partner who agrees to use a male condom with spermicide 6.4. A sterile sexual partner 6.5. True abstinence Part B only: Women suffering from recurrent UTIs, in line with the European Urology Association guideline and the standard clinical practice at the site, diagnosed by a primary care physician or medical specialist, and who are in the quiescent phase of the disease, i.e., who are not presenting any UTI acute-onset symptoms that typically include dysuria in conjunction with variable degrees of increased urinary urgency and frequency, haematuria, and new or worsening incontinence |
| Key exclusion criteria | 1. ECG with clinically significant abnormalities 2. Clinically significant abnormal physical findings, presence of mouth lesions/alteration and of any tongue piercings, partials, braces, dentures 3. Lab analyses with clinically significant abnormalities 4. Ascertained or presumptive hypersensitivity to the active principle and/or formulation ingredients; history of anaphylaxis to drugs or allergic reactions 5. Significant diseases 6. Medications for 2 weeks before study start 7. Participation in the evaluation of any investigational product for 3 months before the study start 8. Blood donations for 3 months before this study 9. History of drug, alcohol, caffeine or tobacco abuse 10. Positive drug test at Day -1 11. Positive alcohol test at screening and Day -1 12. Abnormal diet 13. Positive or missing pregnancy test at screening or day-1, pregnant or lactating women |
| Date of first enrolment | 30/10/2025 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Arzo
6864
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
23/03/2026: The following changes were made to the study record:
1. The date of final enrolment was changed from 31/03/2026 to 31/07/2026.
2. The completion date was changed from to 31/07/2026 to 31/10/2026.
19/01/2026: Study's existence confirmed by the Cantonal Ethics Committee.
