Low Back PainPhase 4NCT01843660

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

A Phase 4 study testing Tramadol HCl-Paracetamol in people with Low Back Pain and Shoulder Pain, run by Xian-Janssen Pharmaceutical Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain, Shoulder Pain, Neck Pain
What is being tested?: Tramadol HCl-Paracetamol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,059 participants
Where: No sites listed yet
Study dates: Sep 2007to May 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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
Being tested: Tramadol HCl-Paracetamol
Keywords: Low back pain, Shoulder pain, Neck pain, Tramadol hydrochloride, Paracetamol
Medical subject headings: Low Back Pain, Shoulder Pain, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tramadol HCl-ParacetamolDrug
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.

Study groups in NCT01843660
Study group	Role	What they receive
Tramadol Hydrochloride (HCl)-Paracetamol	Experimental	Not described Receives: Drug: Tramadol HCl-Paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Hour 0.5
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.
Measured: Hour 1
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.
Measured: Hour 2
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.
Measured: Hour 3
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.
Measured: Hour 4
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.
Measured: Hour 6
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).
Measured: Hour 0.5
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).
Measured: Hour 1
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).
Measured: Hour 2
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).
Measured: Hour 3
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).
Measured: Hour 4
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).
Measured: Hour 6

Secondary outcomes (3)

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.
Measured: Baseline up to Hour 2
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.
Measured: Hour 6
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.
Measured: Hour 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007May 2008

First posted30 Apr 2013 (estimated)
Study startSep 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,059 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01843660
Sponsor's protocol ID: CR016117
Other IDs: TRAMAPPAI4035, TRAMAP-CHN-MA-02
Status last verified: Jun 2013
First submitted: 26 Apr 2013
Last updated: 26 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01843660
Acronym / sponsor ID: CR016117
Conditions: Low Back Pain, Shoulder Pain, Neck Pain
Keywords: Low back pain, Shoulder pain, Neck pain, Tramadol hydrochloride, Paracetamol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,059 participants (actual)
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 30 Apr 2013 (estimated)
Results: Posted 26 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tramadol Hydrochloride (HCl)-Paracetamol	Experimental	Drug: Tramadol HCl-Paracetamol

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tramadol HCl-ParacetamolParticipants 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.	Drug	Tramadol Hydrochloride (HCl)-Paracetamol

Primary outcome

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

3 secondary outcomes

Number of Participants Who Required Additional Dosage Administration
Time frame: Baseline up to Hour 2
Number of Participants With Analgesic Satisfaction Score
Time frame: Hour 6
Number of Participants With Overall Analgesic Satisfaction Score
Time frame: Hour 6

Results and safety

Results posted to the registry on 26 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tramadol Hydrochloride (HCl)-Paracetamol	1,059	1,029

Primary outcome: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5

Time frame: Hour 0.5. Mean (Standard Deviation). Unit: Units on a scale

Measure	Tramadol Hydrochloride (HCl)-Paracetamol n = 1029
Value	5.29 (2.07)

Population analysed: Per protocol population included all participants who completed the clinical trial according to the trial protocol.

Primary outcome: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1

Time frame: Hour 1. Mean (Standard Deviation). Unit: Units on a scale

Measure	Tramadol Hydrochloride (HCl)-Paracetamol n = 1029
Value	4.32 (2.20)

Population analysed: Per protocol population included all participants who completed the clinical trial according to the trial protocol.

Primary outcome: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2

Time frame: Hour 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	Tramadol Hydrochloride (HCl)-Paracetamol n = 1029
Value	3.52 (2.14)

Population analysed: Per protocol population included all participants who completed the clinical trial according to the trial protocol.

Primary outcome: Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3

Time frame: Hour 3. Mean (Standard Deviation). Unit: Units on a scale

Measure	Tramadol Hydrochloride (HCl)-Paracetamol n = 1029
Value	2.93 (2.00)

Population analysed: Per protocol population included all participants who completed the clinical trial according to the trial protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tramadol Hydrochloride (HCl)-Paracetamol	0 of 1,059 (0%)	86 of 1,059 (8.1%)	Not reported

Limitations and caveats (from the sponsor): Results are reported for 'number of participants who required additional dosage administration' instead of 'time to achieve analgesic effect' due to change in planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

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Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director

Xian-Janssen Pharmaceutical Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tramadol HCl-Paracetamol in people with Low Back Pain and Shoulder Pain, run by Xian-Janssen Pharmaceutical Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5 (time frame: Hour 0.5). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.