Clinical trial • Neurology

TAPENTADOL HYDROCHLORIDE for Chronic postoperative pain

Clinical trial of TAPENTADOL HYDROCHLORIDE for Chronic postoperative pain.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Chronic postoperative pain
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
22-07-2024

Trial design

Randomised, placebo (matching) as comparator to tapentadol (palexia retard); specific dose/schedule not specified in the record.-controlled trial in Netherlands.

Randomised
Yes
Comparator
Placebo (matching) as comparator to Tapentadol (PALEXIA Retard); specific dose/schedule not specified in the record.
Target Sample Size
540
Trial Duration For Participant
365

Eligibility

Recruits 540 Vulnerable populations not selected. Participants must be able to give informed consent — exclusion criteria include 'Inability to give informed consent' and 'Inability to communicate with the investigators'. Trial population limited to adults aged 18-80 years..

Pregnancy Exclusion
Pregnancy/lactation;
Vulnerable Population
Vulnerable populations not selected. Participants must be able to give informed consent — exclusion criteria include 'Inability to give informed consent' and 'Inability to communicate with the investigators'. Trial population limited to adults aged 18-80 years.

Inclusion criteria

  • {"criterion_text":"- American Society of Anesthesiologists score 1, 2 or 3"}
  • {"criterion_text":"- Age between 18-80 years"}

Exclusion criteria

  • {"criterion_text":"- 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;"}
  • {"criterion_text":"- Regular use of anti-depressants or anti-epileptics for chronic pain. If this medication is used for another indication than pain participation in the study is allowed."}
  • {"criterion_text":"- 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);"}
  • {"criterion_text":"- Pregnancy/lactation;"}
  • {"criterion_text":"- Use of MAO-inhibitors or rifampicin within the last 14 days before inclusion;"}
  • {"criterion_text":"- Inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders"}
  • {"criterion_text":"- Inability to give informed consent"}
  • {"criterion_text":"- Inability to communicate with the investigators"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessment of development of chronic pain during the first year after surgery; comparison of Tapentadol versus placebo on incidence/severity of chronic postoperative pain in the first year after surgery."}

Recruitment

Planned Sample Size
540
Recruitment Window Months
80
Consent Approach
Informed consent is required from participants; exclusion criterion includes 'Inability to give informed consent'. Participants are adults (18-80 years). An ICF document is listed (ICF for publication, version 4.2). No further details on assent, consent form languages, or consent process are provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
540

Netherlands

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
3
Number Of Sites
1
Number Of Participants
540

Sites

Site Name
Reinier de Graaf Groep
Department Name
Anesthesiology
Contact Person Name
Jurjan van Cosburgh
Contact Person Email
wetenschapsbureau@rdgg.nl

Sponsor

Primary sponsor

Full Name
Leids Universitair Medisch Centrum (LUMC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
PALEXIA Retard 50 mg tabletten met verlengde afgifte
Active Substance
TAPENTADOL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number RVG 110724 (product record present)
Maximum Dose
200 mg

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