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

Primary Purpose

Low Back Pain, Shoulder Pain, Neck Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tramadol HCl-Paracetamol
Sponsored by
Xian-Janssen Pharmaceutical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Shoulder pain, Neck pain, Tramadol hydrochloride, Paracetamol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tramadol Hydrochloride (HCl)-Paracetamol

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    April 26, 2013
    Last Updated
    June 18, 2013
    Sponsor
    Xian-Janssen Pharmaceutical Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01843660
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xian-Janssen Pharmaceutical Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Shoulder Pain, Neck Pain
    Keywords
    Low back pain, Shoulder pain, Neck pain, Tramadol hydrochloride, Paracetamol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1059 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol Hydrochloride (HCl)-Paracetamol
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol HCl-Paracetamol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
    Description
    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.
    Time Frame
    Hour 0.5
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
    Description
    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.
    Time Frame
    Hour 1
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
    Description
    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.
    Time Frame
    Hour 2
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
    Description
    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.
    Time Frame
    Hour 3
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
    Description
    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.
    Time Frame
    Hour 4
    Title
    Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
    Description
    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.
    Time Frame
    Hour 6
    Title
    Number of Participants With Pain Relief Score at Hour 0.5
    Description
    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).
    Time Frame
    Hour 0.5
    Title
    Number of Participants With Pain Relief Score at Hour 1
    Description
    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).
    Time Frame
    Hour 1
    Title
    Number of Participants With Pain Relief Score at Hour 2
    Description
    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).
    Time Frame
    Hour 2
    Title
    Number of Participants With Pain Relief Score at Hour 3
    Description
    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).
    Time Frame
    Hour 3
    Title
    Number of Participants With Pain Relief Score at Hour 4
    Description
    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).
    Time Frame
    Hour 4
    Title
    Number of Participants With Pain Relief Score at Hour 6
    Description
    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).
    Time Frame
    Hour 6
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Required Additional Dosage Administration
    Description
    Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.
    Time Frame
    Baseline up to Hour 2
    Title
    Number of Participants With Analgesic Satisfaction Score
    Description
    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.
    Time Frame
    Hour 6
    Title
    Number of Participants With Overall Analgesic Satisfaction Score
    Description
    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.
    Time Frame
    Hour 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
    Organizational Affiliation
    Xian-Janssen Pharmaceutical Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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