Overview
Sponsor-declared trial summary
chronic postoperative pain
To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to further explore the mechanism behind the development of chronic postoperative pain
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 22 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511010-21-00
- EudraCT number
- 2018-004804-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Pharmacodynamic
To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to further explore the mechanism behind the development of chronic postoperative pain
Secondary objectives 3
- The effect of Tapentadol compared to placebo on acute postoperative pain in patients planned for elective inguinal hernia surgery and knee replacement surgery.
- The influence of the pre-operative pain profile (inhibitory as measured by CPM and facilitatory as measured by the presence of central sensitization) on the de-velopment of chronic postoperative pain in patients with and without chronic pain in the pre-operative phase.
- The influence of Tapentadol and placebo on the individual pain profiles (inhibitory as measured by CPM and facilitatory as measured by the presence of central sensitization) and its influence on the development of chronic postoperative pain.
Conditions and MedDRA coding
chronic postoperative pain
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- American Society of Anesthesiologists score 1, 2 or 3
- Age between 18-80 years
Exclusion criteria 8
- Chronic pain due to any cause other than pain caused by osteoarthritis of the knee or inguinal hernia which in the opinion of the investigator may influence the outcome of the trial;
- Regular use of anti-depressants or anti-epileptics for chronic pain. If this medica-tion is used for another indication than pain participation in the study is allowed.
- Known allergies or contraindication to the study medication according to the SmPC (such as the presence of respiratory depression, severe astma, paralytic ileus and acute intoxications with alcohol, hypnotics or other psychotropic active substances);
- Pregnancy/lactation;
- Use of MAO-inhibitors or rifampicin within the last 14 days before inclusion;
- Inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders
- Inability to give informed consent
- Inability to communicate with the investigators
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The effect of Tapentadol compared to placebo on the development of chronic pain in the first year after surgery in patients planned for elective inguinal hernia surgery and knee replacement surgery.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PALEXIA Retard 50 mg tabletten met verlengde afgifte
PRD417782 · Product
- Active substance
- Tapentadol Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 5700 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AX06 — -
- Marketing authorisation
- RVG 110724
- MA holder
- GRÜNENTHAL B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Monique van Velzen
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Monique van Velzen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 540 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-07-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | C1 Protocol for publication | 4.0 |
| Recruitment arrangements (for publication) | Blank document | na |
| Subject information and informed consent form (for publication) | ICF for publication | 4.2 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_ SmPC Tapentadol | na |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | Netherlands | Acceptable with conditions 2024-07-22
|
2024-07-22 |