Efficacy and Safety of Prolonged Release (SR) Tramadol Hydrochloride (HCl)/Paracetamol fixed combination and Immediate Release (IR) Tramadol HCl/Paracetamol fixed combination in Patients with Moderate to Severe Acute Low-Back Pain - TreaSuRe

Phase 1

• Conditions: Moderate to severe acute low-back pain (12 weeks or less of symptoms).; MedDRA version: 19.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002875-20-HR
• Lead Sponsor: KRKA-FARMA d. o. o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 350

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.
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 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 intensity not exceeding 30 mm on VAS is achieved on the day of therapy discontinuation or at the end of the trial.;Timepoint(s) of evaluation of this end point: After 28 days of treatment