E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe acute low-back pain (12 weeks or less of symptoms). |
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E.1.1.1 | Medical condition in easily understood language |
Moderate to severe acute low-back pain (12 weeks or less of symptoms). |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024891 |
E.1.2 | Term | Low back pain |
E.1.2 | System Organ Class | 100000004859 |
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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 |
Main objective of the trial is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of the medicines Doreta IR and Doreta SR produced by Krka, d.d., Novo mesto, Slovenia in patients with moderate to severe acute low-back pain. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients diagnosed with acute low back pain (12 weeks or less of symptoms).
• Patients whose average pain intensity is more than or equal to 40 millimeters on horizontal Visual Analog Scale (VAS) over the last 48 hours after the completion of screening.
• Female and male patients aged 18-75 years.
• Written informed consent. |
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E.4 | Principal exclusion criteria |
• Hypersensitivity to the active substances or to any of the excipients.
• Patients taking Monoamine oxidase (MAO) inhibitors or are within two weeks of their withdrawal.
• Patients taking neuroleptics or drugs for seizures.
• Severe hepatic impairment.
• Patients on maintenance tramadol and/or paracetamol therapy.
• Patients taking sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants.
• Pregnant, lactating or breastfeeding participants.
• Known or suspected alcohol or drug abuse or addiction within three years preceding screening.
• Patients with unstable angina pectoris or after acute myocardial infarction (4 weeks after acute myocardial infarction).
• Other mental disorders (possible interactions with mental disorder medicines).
• Surgical procedures planned to occur during trial (patients may be rescreened following completion of and recovery from the surgical procedure).
• Concomitant treatment that might influence the final therapeutic effect of the tested active substances.
• Concomitant therapy with either selective serotonin reuptake inhibitors (SSRI) or serotonin–norepinephrine reuptake inhibitors (SNRI).
• Patients who under the opinion of the investigator will not be compliant to the treatment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is to determine the proportion of patients with clinically meaningful improvement of low back pain. Reduction of low back pain intensity is considered as clinically meaningful, if pain reduction equal or more than 30 % (measured by VAS) or if pain intensity on VAS ≤ 30 mm is achieved on the day of therapy discontinuation or at the end of the trial in comparison to the initial level (baseline). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 28 days of treatment |
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E.5.2 | Secondary end point(s) |
The secondary end points of the trial are:
• To determine pain intensity difference (PID): pain intensity evaluated and marked on VAS by patients, using a diary at days 2, 3, 8 and 15.
• To evaluate the influence of therapy with Doreta IR and Doreta SR on the difference of pain intensity (measured by VAS at each control visit and compared to the measurements before the treatment).
• To evaluate the influence of therapy with Doreta® IR and Doreta® SR on the patients' quality of life according to 36-Item Short Form Survey from the RAND Medical Outcomes Study data.
• To evaluate the influence of therapy with Doreta® IR and Doreta® SR on the patients' pain assessment according to Brief pain inventory (Short form).
• To determine the proportion of patients whom pain reduction equal or more than 50 % (measured by VAS) or pain intensity on VAS ≤ 30 mm was achieved on the day of therapy discontinuation in comparison to the initial level (baseline).
• To determine the proportion of patients with reduced pain (VAS ≤ 30 mm) after each control visit.
• To evaluate the proportion of patients with eliminated pain (VAS ≤ 10 mm; % ELIMday7, % ELIMday14, % ELIMday28) after each control visit.
• To evaluate the proportion of compliant patients. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 28 days of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Different dosage forms and doses of the tramadol/paracetamol combination |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |