Clinical trial NCT01843660: An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Shoulder Pain
Neck Pain
Keywords: Low back pain
Shoulder pain
Neck pain
Tramadol hydrochloride
Paracetamol
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 1059
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
timeFrame: Hour 0.5
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
timeFrame: Hour 1
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
timeFrame: Hour 2
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
timeFrame: Hour 3
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
timeFrame: Hour 4
measure: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
timeFrame: Hour 6
measure: Number of Participants With Pain Relief Score at Hour 0.5
timeFrame: Hour 0.5
measure: Number of Participants With Pain Relief Score at Hour 1
timeFrame: Hour 1
measure: Number of Participants With Pain Relief Score at Hour 2
timeFrame: Hour 2
measure: Number of Participants With Pain Relief Score at Hour 3
timeFrame: Hour 3
measure: Number of Participants With Pain Relief Score at Hour 4
timeFrame: Hour 4
measure: Number of Participants With Pain Relief Score at Hour 6
timeFrame: Hour 6
Secondary outcomes:
measure: Number of Participants Who Required Additional Dosage Administration
timeFrame: Baseline up to Hour 2
measure: Number of Participants With Analgesic Satisfaction Score
timeFrame: Hour 6
measure: Number of Participants With Overall Analgesic Satisfaction Score
timeFrame: Hour 6
Other outcomes:
Locations:
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: