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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843660
• Other study ID #: CR016117
• Secondary ID: TRAMAPPAI4035TRA
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2013
• Last updated: June 18, 2013
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2013
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1059
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neck Pain
• Shoulder Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 0.5	No
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 1	No
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 2	No
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 3	No
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 4	No
Primary	Pain Intensity Score Based on Numeric Rating Scale (NRS) at 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.	Hour 6	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 0.5	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 1	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 2	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 3	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 4	No
Primary	Number of Participants With Pain Relief Score at 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).	Hour 6	No
Secondary	Number of Participants Who Required Additional Dosage Administration	Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.	Baseline up to Hour 2	No
Secondary	Number of Participants With Analgesic Satisfaction Score	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.	Hour 6	No
Secondary	Number of Participants With Overall Analgesic Satisfaction Score	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.	Hour 6	No