Fibromyalgia MedDRA version: 18.1 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Pallexia
Product Name: Tapenatdol
Product Code: N02AX06
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
LUMC
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 =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show efficacy of tapentadol in causing pain relief in patients with fibromyalgia which may be predict by specific patient phenotypes based on CCM, QST and CPM.;Secondary Objective: None;Primary end point(s): CPM response Pain relief;Timepoint(s) of evaluation of this end point: 1, 2 and 3 months (during treatment), 1 month after treatment ended | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Netherlands
Contacts
Public ContactProfessor of Anesthesiology
LUMC
Outcome results
None listed