chronic low back pain MedDRA version: 12.0 Level: LLT Classification code 10024891 Term: Low back pain
Conditions
Interventions
Trade Name: Katadolon® S long
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: FLUPIRTINE MALEATE
CAS Number: 75507685
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
AWD.pharma GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • male or female patients, aged 18 to 75 (inclusive) • chronic low back pain (>12 weeks) • pretreatment with either NSAIDs, cox-2 inhibitors, dipyrone or paracetamol as recommended by national LBP treatment guidelines • mild to moderate stage of pain chronification (stage I or II) according to the Mainz Pain Staging System (MPSS). • an average pain intensity classified as moderate to severe pain intensity at baseline (i.e. at least “4” on the NRS-11 or at least “moderate” on the VRS-5). • significant worsening of pain intensity after discontinuation of the pre-study medication with a deterioration of both, the lowest and average low back pain intensity index (LBPI) of at least 1 point on the NRS-11 and one point on the 5-point patient global assessment of response to therapy (PGART) scale • women of childbearing potential must use a reliable method of contraception • patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Lack of suitability for the trial • a rating of the patient global assessment of disease status (PGADS) as very poor • no significant worsening of the LBPI after discontinuation of the pre-study medication • back pain caused by any spinal fracture (e.g. osteoporotic crush). • history of any surgery in the back. • clinical and radiological evidence of Bechterew’s or Paget’s disease. • clinical signs for acute nerve root lesion (hyporeflexia, weakness, dermatomal sensory deficite). • acute back pain caused by soft tissue damage. • malignant diseases with involvement of the spinal column. • metabolic bone diseases. • chronic inflammatory diseases of the spinal column due to Psoriasis arthritis, Reiter syndrome, arthritides in connection with enteropathies (Colitis ulcerosa, M. Crohn). • necessity for simultaneous administration of not permitted medication during the study (incl. topical preparations applied to the pain area, local injections). • necessity of other concomitant, pain relieving therapy measures during the study. • concomitant disease: clinically significant abnormalities on pre-examination, vital signs, ECG or laboratory tests. • pain-free states during daytime during the screening period (as stated in the patient diary). • tailored treatment targets of “0” or “1” at baseline (NRS-11). • hepatic impairment and increased liver enzymes (GOT, GPT and GGT, ? twice the upper reference range). • neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects proper completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to demonstrate either non-inferior pain relieving effects of the modified-release formulation of flupirtine (400mg OD in the evening) in comparison to extended-release tramadol (200mg OD in the evening) as well as a superior analgesic efficacy of flupirtine MR (400mg OD in the evening) in comparison to placebo in patients suffering from moderate to severe chronic low back pain (CLBP) after a four week treatment course.;Secondary Objective: Secondary objectives focus on the differential impact of the treatment with flupirtine or tramadol on pain-related disabilities in daily life activities, on the health-related quality-of-life and the overall efficacy with respect to the different stages of chronification.;Primary end point(s): Primary: This study follows a combined non-inferiority/superiority design comparing the analgesic efficacy of the modified-release formulation of flupirtine to those of the extended-release formulation of tramadol (non-inferiority) and to placebo (superiority). The change in the low back pain intensity index after a four week treatment course with either modified-release flupirtine, extended-release tramadol or placebo will be analyzed as primary endpoint using an adjusted analysis of covariance (ANCOVA) model including disease duration and pre-study analgesic medication as terms and the baseline LBPI as a covariate. If necessary further baseline parameters significantly affecting the pre-study balance across treatment arms will be taken into account as covariates to adjust for any imbalances and potential confounders that occur despite randomization. The alternative (working) hypotheses are … a) … that the analgesic efficacy of modified-release flupirtine (400mg OD) in chronic low back pain patients is over a four week treatment course superior to placebo; b) … that the analgesic efficacy of modified-release flupirtine (400mg) in chronic low back pain patients is over a four week tr | — |
Countries
Germany
Outcome results
None listed