CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 538 enrolled
Drug / intervention
Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg +2 moredrug
Likely dose
Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05170841
NCT05170841Phase 4Completed
CompareCT.gov

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

Menarini International Operations Luxembourg SA·interventional·Posted Dec 28, 2021·Updated Jan 9, 2025

In Brief

A Phase 4 clinical trial evaluating Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg, Tramadol Hydrochloride 100 mg, and 1 other intervention for Low Back Pain. Completed, enrolled 538 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 28, 2021
Enrollment StartSep 17, 2020
Primary CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.5 years ago

Interventions

Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mgdrug

Administered as one single tablet to be taken every 8 hours

Tramadol Hydrochloride 100 mgdrug

Administered as two capsules with 50 mg each to be taken every 8 hours

Placebodrug

Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg