Overview
Sponsor-declared trial summary
Lung cancer
The aim is to conduct a randomized controlled trial with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to “High-pain-responders” in patients undergoing VATS lobectomy/segmentectomy.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 28 Aug 2025 → ongoing
- Decision date (initial)
- 2025-04-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim is to conduct a randomized controlled trial with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to “High-pain-responders” in patients undergoing VATS lobectomy/segmentectomy.
Conditions and MedDRA coding
Lung cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age >18 years
- Able to understand written and spoken Danish language
- Pain Catastrophizing Scale ≥ 20
- Patient planned to elective Video-Assisted Thoracoscopic Surgery Lobectomy/Segmentectomy
Exclusion criteria 10
- Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, excluding inhaled steroids.
- Individuals with diabetes requiring insulin treatment.
- Pregnant or breastfeeding patients.
- Patients with known allergies to the study drug.
- Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.
- Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications
- Individuals with altered pain perception due to other conditions or injuries, such as spinal cord or brain injuries, severe polyneuropathies, or neurological disorders
- Regular users of opioid medications.
- Patients requiring reoperation within the first two postoperative days
- Individuals undergoing conversion to a surgical procedure other than VATS lobectomy/segmentectomy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain when coughing on the morning on POD1 (Numeric Rating Scale 0-10)
Secondary endpoints 12
- Pain at 5-meter walk test in the morning and afternoon POD1+2 (NRS)
- Pain when coughing on the afternoon POD1 + morning and afternoon POD2 (NRS)
- Postoperative length of stay (in days)
- Cumulative use of rescue analgesics per day during POD1+2
- Cumulative use of rescue antiemetics per day during POD1+2
- Reasons for re-admission within 30 days (defined as overnight hospital stay after discharge)
- Intensive Care Unit Days
- Pain Catastrophizing Scale (PCS)
- Morbidity and mortality (30-day)
- Quality of recovery questionnaire (QoR15) in day 7
- Nausea (NRS)
- Episodes of vomiting
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dexavit, injektions-/infusionsvæske, opløsning
PRD5493076 · Product
- Active substance
- Dexamethasone Disodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 55739
- MA holder
- XGX PHARMA APS
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Lasse Visby
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Lasse Visby
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-08-28 | 2025-08-28 |
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) | Pain Catastrophizing Scale | 1 |
| Protocol (for publication) | Protocol | 3 |
| Protocol (for publication) | Signature sheet | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 1 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin _ De Videnskabsetiske Komiteer | 1 |
| Subject information and informed consent form (for publication) | Informed consent form | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Denmark | Acceptable 2025-04-02
|
2025-04-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-14 | Denmark | Acceptable 2025-04-02
|
2025-07-14 |