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

NCT01843660 | Completed Phase 4 Results

• 3 other identifiers: CR016117TRAMAPPAI4035TRAMAP-CHN-MA-02
• Study Type: interventional
• Target: 1,059
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Shoulder Pain; Neck Pain

Keywords

Low back pain; Shoulder pain; Neck pain; Tramadol hydrochloride; Paracetamol

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• Number of Participants Who Required Additional Dosage Administration

  Baseline up to Hour 2

• Number of Participants With Analgesic Satisfaction Score

  Hour 6

• Number of Participants With Overall Analgesic Satisfaction Score

  Hour 6

Study Arms (1)

Tramadol Hydrochloride (HCl)-Paracetamol

EXPERIMENTAL

Drug: Tramadol HCl-Paracetamol

Interventions

Tramadol HCl-Paracetamol DRUG

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.

Tramadol Hydrochloride (HCl)-Paracetamol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

MeSH Terms

Conditions

Low Back Pain; Shoulder Pain; Neck Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Therapeutic Area Physician
• Organization: Janssen China, Beijing

+86-10-58218709

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: September 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 26, 2013
• Results First Posted: August 26, 2013

Record last verified: 2013-06