CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,059 enrolled
Drug / intervention
Tramadol HCl-Paracetamoldrug
Likely dose
Tramadol HCl-Paracetamol 37.5 milligramfrom 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/NCT01843660
NCT01843660Phase 4Completed
CompareCT.gov

The Clinical Efficacy and Safety Study of Tramadol Hydrochloride - Paracetamol Tablets in the Treatment of Moderate to Severe Acute Neck-shoulder Pain and Low Back Pain in Orthopaedics Outpatient or Emergency Setting

Xian-Janssen Pharmaceutical Ltd.·interventional·Posted Apr 30, 2013·Updated Aug 26, 2013

In Brief

A Phase 4 clinical trial evaluating Tramadol HCl-Paracetamol for Low Back Pain and 2 related conditions. Completed, enrolled 1,059 participants.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Shoulder Pain, Neck Pain
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 30, 2013
Enrollment StartSep 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.2 years ago

Interventions

Tramadol HCl-Paracetamoldrug

Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.