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An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain

Low Back Pain Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01843660
Study type Interventional
Source Xian-Janssen Pharmaceutical Ltd.
Contact
Status Completed
Phase Phase 4
Start date September 2007
Completion date May 2008
View Details
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