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

NCT ID: NCT01843660

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1059 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

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.

Conditions

Low Back Pain; Shoulder Pain; Neck Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tramadol Hydrochloride (HCl)-Paracetamol

Group Type: EXPERIMENTAL

Tramadol HCl-Paracetamol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Role: STUDY_DIRECTOR

Xian-Janssen Pharmaceutical Ltd.

Other Identifiers

TRAMAPPAI4035

Identifier Type: -

Identifier Source: secondary_id

TRAMAP-CHN-MA-02

Identifier Type: -

Identifier Source: secondary_id

CR016117

Identifier Type: -

Identifier Source: org_study_id