CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 606 enrolled
Drug / intervention
Placebo +6 moredrug
Likely dose
Not stated in 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/NCT01904149
NCT01904149Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy

Menarini Group·interventional·Posted Jul 22, 2013·Updated Apr 1, 2016

In Brief

A Phase 3 clinical trial evaluating Placebo, Dexketoprofen-single dose, and 5 other interventions for Acute Pain. Completed, enrolled 606 participants across 28 sites in 8 countries.

Detailed Summary

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only). Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesHungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.9 years ago

Interventions

Placebodrug

Placebo single oral dose (first 8 hours)

Dexketoprofen-single dosedrug

Dexketoprofen single oral dose (first 8 hours)

Tramadol-single dosedrug

Tramadol single oral dose (first 8 hours)

Dexketoprofen/Tramadol-single dosedrug

Dexketoprofen/Tramadol single oral dose (first 8 hours)

Dexketoprofen-multiple dosesdrug

Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)

Tramadol-multiple dosesdrug

Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Dexketoprofen/Tramadol-multiple dosesdrug

Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)