[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100197238":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":11,"locations":11,"responsibleParty":24,"collaborators":11,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":33,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":48,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Xian-Janssen Pharmaceutical Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tramadol Hydrochloride (HCl)-Paracetamol","EXPERIMENTAL",null,[13],"Drug: Tramadol HCl-Paracetamol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Tramadol HCl-Paracetamol","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.",[9],[21],{"name":22,"affiliation":5,"role":23},"Xian-Janssen Pharmaceutical Ltd., China Clinical Trial","STUDY_DIRECTOR",{"type":25,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100197238","phase-4-an-efficacy-and-safety-study-of-tramadol-hydrochloride-paracetamol-in-treatment-of-moderate-to-severe-acute-neck-shoulder-pain-and-low-back-pain-100197238",true,"NCT01843660","An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain","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","Inclusion Criteria:\n\n* Intermittent or persistent pain for less than 3 months, required analgesic therapy, orthopedic surgery and emergency call participants suffering with severe neck, shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and severe form of illness in its early stage) exacerbation pain\n* Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)\n* During normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary\n* Be willing to participate in the study and must give written informed consent\n\nExclusion Criteria:\n\n* Have used strong opium kind of medication 7 days prior to the enrolment\n* Have severe mental disease or using antipsychotic (agent that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) medication for medical treatment\n* Drug abuse\u002Fdependence, or chronic alcohol abuse\u002Fdepend on history\n* Pregnant or lactating women\n* Unable to tolerate tramadol or any failed treatment in past by using tramadol\n* Comparatively more severe pain in other parts of the body than that of the pain mentioned in the research",false,"ALL","18 Years","65 Years",{"count":38,"type":39},1059,"ACTUAL","INTERVENTIONAL",[42],"PHASE4","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.",[45,46,47],"Low Back Pain","Shoulder Pain","Neck Pain",[49,50,51,52,53],"Low back pain","Shoulder pain","Neck pain","Tramadol hydrochloride","Paracetamol","COMPLETED","2013-06-18",{"date":57,"type":58},"2013-08-26","ESTIMATED",{"date":60,"type":11},"2007-09",{"date":62,"type":39},"2008-05",{"name":5,"class":6}]