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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

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ClinicalTrials.gov Identifier: NCT01843660
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : August 26, 2013
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Shoulder Pain Neck Pain Drug: Tramadol HCl-Paracetamol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1059 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Tramadol Hydrochloride (HCl)-Paracetamol 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.




Primary Outcome Measures :
  1. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5 [ Time Frame: 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.

  2. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1 [ Time Frame: 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.

  3. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2 [ Time Frame: 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.

  4. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3 [ Time Frame: 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.

  5. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4 [ Time Frame: 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.

  6. Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6 [ Time Frame: 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.

  7. Number of Participants With Pain Relief Score at Hour 0.5 [ Time Frame: 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).

  8. Number of Participants With Pain Relief Score at Hour 1 [ Time Frame: 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).

  9. Number of Participants With Pain Relief Score at Hour 2 [ Time Frame: 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).

  10. Number of Participants With Pain Relief Score at Hour 3 [ Time Frame: 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).

  11. Number of Participants With Pain Relief Score at Hour 4 [ Time Frame: 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).

  12. Number of Participants With Pain Relief Score at Hour 6 [ Time Frame: 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 :
  1. Number of Participants Who Required Additional Dosage Administration [ Time Frame: 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.

  2. Number of Participants With Analgesic Satisfaction Score [ Time Frame: 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.

  3. Number of Participants With Overall Analgesic Satisfaction Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843660


Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
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Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.

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Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01843660     History of Changes
Other Study ID Numbers: CR016117
TRAMAPPAI4035
TRAMAP-CHN-MA-02
First Posted: April 30, 2013    Key Record Dates
Results First Posted: August 26, 2013
Last Update Posted: August 26, 2013
Last Verified: June 2013

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Low back pain
Shoulder pain
Neck pain
Tramadol hydrochloride
Paracetamol

Additional relevant MeSH terms:
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Tramadol
Back Pain
Low Back Pain
Neck Pain
Shoulder Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants