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: 19.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002875-20-PL
• Lead Sponsor: Krka d.d., Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-19
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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