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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Shoulder Pain

Neck Pain

Low Back Pain

Treatments

Drug: Tramadol HCl-Paracetamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01843660

TRAMAP-CHN-MA-02

TRAMAPPAI4035

CR016117

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,059 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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