NCT05170841

Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain

Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Menarini International Operations Luxembourg SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.

Detailed description

This is a multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled study encompassing 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until day 5). Study population will be of male or female patients aged 18 years to 65 years with acute low back pain of moderate to severe intensity, whose onset of the current acute low back pain episode is within 48 hours prior to Screening. Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification. Patients experiencing a new episode of low back pain will be eligible only if preceded by a period of at least 2 months without any low back pain. Patients should be free from analgesic due to previously administered pain killer (immediate or slow release formulations), according to exclusion criteria. Approximately 612 patients will be screened to achieve 510 patients randomly assigned to study treatment. In the single-dose phase patients will receive a single-dose treatment, consisting of 1 film-coated tablet and 2 capsules which have to be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 milligram (mg) during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg	Administered as one single tablet to be taken every 8 hours
DRUG	Tramadol Hydrochloride 100 mg	Administered as two capsules with 50 mg each to be taken every 8 hours
DRUG	Placebo	Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg

Timeline

• Start date: 2020-09-17
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2021-12-28
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: Italy