Overview
Sponsor-declared trial summary
Medical expulsive therapy using diuretics and alpha-blockers after shock wave lithotripsy of kidney stones
We would like to evaluate the effect of combined alpha-blocker (Tamsulosin) and diuretic (Furosemid) in respect to clearance of stone fragments following ESWL. Our hypothesis is that a supplement of Tamsulosin along with Furosemid will increase the effectivity of the treatment. It will thereby reduce the number of ESWL…
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Decision date (initial)
- 2025-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
We would like to evaluate the effect of combined alpha-blocker (Tamsulosin) and diuretic (Furosemid) in respect to clearance of stone fragments following ESWL. Our hypothesis is that a supplement of Tamsulosin along with Furosemid will increase the effectivity of the treatment. It will thereby reduce the number of ESWL treatments and will reduce pain intensity and the need for pain medication after ESWL.
Conditions and MedDRA coding
Medical expulsive therapy using diuretics and alpha-blockers after shock wave lithotripsy of kidney stones
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-510792-38-00 | Medical expulsive therapy using diuretics and alpha-blockers after shock wave lithotripsy of kidney stones | Region Midtjylland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Patients with kidney and proximally located ureteral stones with diameter < 2 cm • Patients >18 years • Able to understand the study procedures and willing to provide signed informed consent
Exclusion criteria 1
- • Symptoms of urinary tract infection • Ureteral or nephrostomy stent placement prior to the intervention • Multiple stones • Renal functional deterioration • Severe hydronephrosis • Hypotension • Solitary kidney • Ectopic kidney and other anatomical anomalies • Patients have other disorders such as heart disease, kidney failure • Positive pregnancy test or fertile women without safety contraception • Allergy to one of the ingredients in the trial medicine
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Stone clearance: A stone-free condition is defined as the complete absence of any stone or the presence of residual fragments smaller than 3 mm in diameter and should be evaluated 4 weeks after last treatment with Non-contrast CT.
Secondary endpoints 1
- Clinical outcomes and success as measured in terms of stone-free rate after ESWL is strongly correlated to pain experienced during and after the treatment. The secondary outcomes will be: • Compare pain during and post ESWL period using a validated VAS. Combination of the two types of medicine is going to be evaluated on the degree of the pain relief. The intensity of their pain will be assessed in three phases; • During the two sessions of ESWL and 2 weeks after the last procedure.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD2945653 · Product
- Active substance
- Furosemide
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 3360 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03CA01 — FUROSEMIDE
- Marketing authorisation
- PL 39484/0021
- MA holder
- FOURRTS (UK) PHARMACARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tamsulosin Krka 0,4 mg Retardtabletten
PRD2668252 · Product
- Active substance
- Tamsulosin Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 µg microgram(s)
- Max total dose
- 11200 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- G04CA02 — TAMSULOSIN
- Marketing authorisation
- 1-29914
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Paracetamol Orifarm 500 mg filmdragerade tabletter
PRD1162187 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 168000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 48797
- MA holder
- ORIFARM GENERICS A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ibuprofen Bluefish 400 mg film-coated tablets
PRD10032528 · Product
- Active substance
- Ibuprofen
- Substance synonyms
- (RS)-2-(4-isobutylphenyl)propionic acid, 2-(4-isobutylphenyl)propionic acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 50400 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- M01AE01 — IBUPROFEN
- Marketing authorisation
- 123456
- MA holder
- BLUEFISH PHARMACEUTICALS AB
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Hospitalsparken 15
- City
- Herning
- Postcode
- 7400
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Sükrü Topcu
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Sükrü Topcu
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 420 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Medical Expulsive Therapy _clean ny trial number | 5 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Informed consent-Samtykke | 2 |
| Subject information and informed consent form (for publication) | SUBJECT INFORMATION | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | PART1_E1_IB Furosemid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PART1_E1_IB Tamsulosin | 1 |
| Synopsis of the protocol (for publication) | Lgmands resume | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-02 | Denmark | Not acceptable 2025-02-25
|
2025-02-26 |