Overview
Sponsor-declared trial summary
Obesity and Obstructive Sleep apnoea
It is expected that the trial will produce important knowledge on the safety and efficacy of morphine for perioperative pain, which will be beneficial for future surgical patients, in particular for bariatric patients suffering from obstructive sleep apnoea subjected to bariatric surgery. Furthermore, we aim to gai…
Key facts
- Sponsor
- Sydvestjysk Sygehus
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03], Diseases [C] - Hormonal diseases [C19], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 1 Dec 2022 → 16 Dec 2025
- Decision date (initial)
- 2022-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Syd · Regional Hospital of South Western Denmark · University of Southern Denmark
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacogenetic, Pharmacokinetic
It is expected that the trial will produce important knowledge on the safety and efficacy of morphine for perioperative pain, which will be beneficial for future surgical patients, in particular for bariatric patients suffering from obstructive sleep apnoea subjected to bariatric surgery.
Furthermore, we aim to gain from new insights and understanding of the pharmacokinetics and pharmacodynamics of morphine – which to this day is a first line drug when acute pain-relief is needed. We aim to further our knowledge and understanding of a more personalized approach to the treatment of acute peri- and postoperative pain, i.e. delivering sufficient pain-relief with an absolute minimum of side effects.
Conditions and MedDRA coding
Obesity and Obstructive Sleep apnoea
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10059610 | Obesity surgery | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Obesity
- Obstructive sleep apnoea
Exclusion criteria 12
- Known allergy towards morphine
- Inability to present a negative pregnancy test
- History of substance abuse
- History of mayor psychiatric illness
- Severe acute respiratory affection, i.e. airway infections
- Increased intracranial pressure
- Severe decreased renal or hepatic function
- Severe COPD or asthma
- Known history of severe chronic pain
- Severe heart failure
- Female participants that are breastfeeding
- Intake of alcohol within 24 hours before start of the trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoints is the area under the curve (AUC)morphine, and maximum plasma concentration (CMAX)morphine
Secondary endpoints 1
- The secondary endpoints is reported stimulus intensity during the Heat, Cold, Bone and Muscle Pressure Tests, ie the quantitive sensory testing
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14596MIG · Substance
- Active substance
- Morphine Hydrochloride
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS
- 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
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03382MIG · Substance
- Active substance
- Naloxone Hydrochloride
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sydvestjysk Sygehus
- Sponsor organisation
- Sydvestjysk Sygehus
- Address
- Finsensgade 35
- City
- Esbjerg
- Postcode
- 6700
- Country
- Denmark
Scientific contact point
- Organisation
- Sydvestjysk Sygehus
- Contact name
- Primary Investigator
Public contact point
- Organisation
- Sydvestjysk Sygehus
- Contact name
- Primary Investigator
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 140 | 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 | 2022-12-01 | 2025-12-16 | 2022-12-01 | 2025-12-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1 |
| Recruitment arrangements (for publication) | Recruitment material - patients | 1 |
| Recruitment arrangements (for publication) | Recruitment material - volunteers | 1 |
| Recruitment arrangements (for publication) | Recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation patienter | 3 |
| Subject information and informed consent form (for publication) | Deltagerinformation raske frivillige | 3 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | Fr du beslutter dig | 1 |
| Subject information and informed consent form (for publication) | HADS - Hospital Anxiety and Depression Scale | 1 |
| Subject information and informed consent form (for publication) | PCS - Pain Catastriphizing Scale | 1 |
| Subject information and informed consent form (for publication) | PQAS - Pain Assessment Scale | 1 |
| Subject information and informed consent form (for publication) | PSQI - Pittsburgh Sleep Quality Index | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 3 |
| Subject information and informed consent form (for publication) | Samtykkeerklring RFI 4 biologisk materiale | 3 |
| Subject information and informed consent form (for publication) | STAI - Spielberger State-Trait anxiety Inventory | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Morfin SAD injektionsvske produktresume | 1 |
| Synopsis of the protocol (for publication) | Lgmandsresume | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-23 | Denmark | Acceptable 2022-09-23
|
2022-09-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-13 | Denmark | Acceptable 2022-09-23
|
2025-06-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-27 | Denmark | Acceptable 2025-06-30
|
2025-06-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-16 | Denmark | Acceptable 2025-06-30
|
2025-12-16 |