E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the study is to investigate the clinical efficacy of the pain relieving effects of the modified release formulation of flupirtine in a daily dosage of 400 and 800 mg as compared to placebo in patients suffering from moderate to severe chronic low back pain. |
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E.2.2 | Secondary objectives of the trial |
A secondary objective is to investigate the impact of the modified release formulation of flupirtine on pain sensitivity (pressure threshold) and tissue compliance of muscles in the affected back region compared with placebo. Safety and tolerability of the MR formulation will be descriptively evaluated based on adverse events, vital signs and laboratory parameters.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Diagnosis: Moderate to severe chronic low back pain (3 – 12 months) at stage II – III as per “Mainzer Pain Staging System” (MPSS) according to GERBERSHAGEN • Back pain intensity rated as at least 5 on an 11-point Numerical Pain Rating Scale (NRS-11) and/or at least moderate on a 5-Point Verbal Rating Scale (VRS-5) before randomisation (at Visit 1) • Male or female patients, aged 18 to 75 • Women of childbearing potential must use a reliable method of contraception (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) • The 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
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E.4 | Principal exclusion criteria |
Lack of suitability for the trial • 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 disease 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 (e.g. physiotherapy) • Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects proper completion of the study. • Exposure to another investigational agent within the last 30 days • Patients who are unable to co-operate Safety concerns • Contraindications of flupirtine like history of allergic reaction to flupirtine or to excipients of the pharmaceutical preparation, risk for hepatic encephalopathy, cholestasis, myasthenia gravis • Contraindications of tramadol like history of hypersensitivity to tramadol or to excipients of the pharmaceutical preparation; concomitant treatment with monoaminooxidase inhibitors; acute poisoning with alcohol or hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs; epilepsy with insufficient treatment • Lactating female or female of child-bearing potential not employing adequate contraception. Administrative reasons • Lack of ability or willingness to give informed consent • Anticipated non-availability for study visits/procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects with a meaningful relief of the overall low-back pain intensity (defined either as at least 30% pain reduction assessed with an 11-point Numerical Pain Rating Scale (NRS-11), or as at least 2-point reduction measured on the basis of a 5-point Verbal Rating Scale (VRS-5)) following treatment with flupirtine compared to placebo. Differences between Visit 4 and baseline (Visit 1) will be used for the primary endpoint assessments of this study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |