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

Phase 4

Completed

• Conditions: Low Back Pain; Shoulder Pain; Neck Pain
• Interventions: Drug: Tramadol HCl-Paracetamol

• Registration Number: NCT01843660
• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.

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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Status Verified: 2013-06
• Results First Submitted: 2013-06-18
• Results First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Results First Posted: 2013-08-26
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1059

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tramadol Hydrochloride (HCl)-Paracetamol	Tramadol HCl-Paracetamol	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5	Hour 0.5	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1	Hour 1	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2	Hour 2	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3	Hour 3	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4	Hour 4	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6	Hour 6	Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Number of Participants With Pain Relief Score at Hour 0.5	Hour 0.5	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 1	Hour 1	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 2	Hour 2	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 3	Hour 3	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 4	Hour 4	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Number of Participants With Pain Relief Score at Hour 6	Hour 6	Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Required Additional Dosage Administration	Baseline up to Hour 2	Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.
Number of Participants With Analgesic Satisfaction Score	Hour 6	Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.
Number of Participants With Overall Analgesic Satisfaction Score	Hour 6	Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.