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

NCT05170841 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2025-01-09

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Menarini International Operations Luxembourg SA

    lead INDUSTRY

Principal Investigators

  • Giustino Varrassi, Professor · University of L'Aquila

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2022-05-04
Completion
2022-05-04

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05170841 on ClinicalTrials.gov