Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 9:25 AM
Study NCT ID:
NCT01843660
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2013-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: