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A study on the efefct of the analgesic tapentadol on pain scores in patients with low back pain

A randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic low back pain - LCAT

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-005259-28-NL
Enrollment
Unknown
Registered
2015-12-17
Start date
2016-02-22
Completion date
Unknown
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain MedDRA version: 18.1 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859 MedDRA version: 18.1 Level: LLT Classification code 10024892 Term: Low back pain (without radiation) System Organ Class: 100000004859

Interventions

Trade Name: Palexia Product Name: Tapentadol Product Code: N02AX06 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

LUMC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age: 18 – 75 years. - Sex: Either sex. - Inclusion criteria: American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI 3-months with a pain score of 3 or more on a numerical rating scale. To be enrolled in part 2 of the study, patients need to have an absent/inactive CPM response. The abnormal CPM response is defined in paragraph 5.2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use; (ix) previous extensive spinal surgery or spinal surgery in the past 6 months; (x) serious spinal pathology and (xi) diagnosed neurological disease.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: NA;Primary end point(s): Pain relief, CPM response;Timepoint(s) of evaluation of this end point: Month 1-2-3-4 following start of treatment;Main Objective: To assess the effect of tapentadol on pain relief in patients with chronic low back pain, and assess whether we can identify specific predictors of effect, incl. CPM, QST, questionnaires.—

Secondary

MeasureTime frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA—

Countries

Netherlands

Contacts

Public ContactAnestehsia & Pain research Unit

LUMC

a.dahan@lumc.nl31715269111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026