Status:
COMPLETED
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Low Back Pain
Shoulder Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 nec...
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 prospec...
Eligibility Criteria
Inclusion
- 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
- 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)
- During normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary
- Be willing to participate in the study and must give written informed consent
Exclusion
- Have used strong opium kind of medication 7 days prior to the enrolment
- 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
- Drug abuse/dependence, or chronic alcohol abuse/depend on history
- Pregnant or lactating women
- Unable to tolerate tramadol or any failed treatment in past by using tramadol
- Comparatively more severe pain in other parts of the body than that of the pain mentioned in the research
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1059 Patients enrolled
Trial Details
Trial ID
NCT01843660
Start Date
September 1 2007
End Date
May 1 2008
Last Update
August 26 2013
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