NCT01112267

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P25-P50 for phase_3 low-back-pain

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3 low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 24, 2013

Completed
Last Updated

July 24, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

April 1, 2010

Results QC Date

April 1, 2013

Last Update Submit

June 20, 2013

Conditions

Low Back Pain

Keywords

Chronic low back painTramadol Hydrochloride (HCl)acetaminophen

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Reduction in Pain Intensity

    The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.

    Baseline up to Day 29

  • Change From Baseline in Pain Intensity at Day 29

    Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.

    Baseline and Day 29

Secondary Outcomes (5)

  • Percentage of Participants With Pain Relief

    Day 8, Day 15 and Day 29

  • Change From Baseline in Short Form (SF)-36 Score at Day 29

    Baseline and Day 29

  • Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29

    Baseline and Day 29

  • Percentage of Participants With Investigator's Global Assessment on Investigational Product

    Day 29

  • Percentage of Participants With Participants' Global Assessment on Investigational Product

    Day 29

Study Arms (2)

Tramadol Hydrochloride (HCl)/acetaminophen

EXPERIMENTAL

Participants will receive 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.

Drug: Tramadol HCl/acetaminophen Extended Release

Placebo

PLACEBO COMPARATOR

Prticipants will receive 1 tablet matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.

Drug: Placebo

Interventions

Tramadol HCl/acetaminophen Extended ReleaseDRUG

Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7

Also known as: Ultracet Extended Relaese
Tramadol Hydrochloride (HCl)/acetaminophen
PlaceboDRUG

Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7

Placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants diagnosed with low back pain at least 3 months before the screening or washout period
  • Participants who have taken a stable dose of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (drugs used for reducing inflammation and pain ) or Cyclo-Oxygenase 2 (COX-2) selective inhibitors (an anti-inflammatory drug that fights pain) from 7 days before investigational product administration, and could maintain the same dose during the period of the study
  • Participants whose average pain intensity is more than or equal to 4.0 centimeters on Visual Analog Scale over the last 48 hours after the completion of screening
  • Postmenopausal or surgically sterile or abstinent women or practicing a highly effective method of birth control
  • Women with childbearing potential must have negative pregnancy test

You may not qualify if:

  • Participants who have taken tramadol or tramadol HCl or acetaminophen, or narcotic (strong habit-forming drug that stops pain and depresses the central nervous system) analgesic tablet within 30 days before investigational product administration
  • Participants who have taken acetaminophen tablet within 7 days before investigational product administration
  • Participants with tumor or infection in meninges or spinal cord
  • Participants who have fibromyalgia (neurosensory disorder characterized by muscle pain, joint stiffness, and fatigue), reflex sympathetic dystrophy (feeling of pain associated with evidence of minor nerve injury) or causalgia (persistent, severe burning sensation of the skin), acute spinal cord compression, acute nerve root compression, severe lower extremity weakness or numbness, regional pain syndrome, meningitis (inflammation of the meninges), diskitis (nonbacterial inflammation of an intervertebral disk or disk space), back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm
  • Participants who have taken analgesic (including local agents or anesthetics), sedative-hypnotic (e.g., diazepam), or muscle relaxant other than a stable dose of NSAIDs or COX-2 selective inhibitors within 5 times the half-life of the concerned agent before investigational product administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lee JH, Lee CS; Ultracet ER Study Group. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013 Nov;35(11):1830-40. doi: 10.1016/j.clinthera.2013.09.017. Epub 2013 Oct 30.

    PMID: 24183364DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Therapeutic area Scientist
Organization
Janssen Korea/ Seoul
+82-2-2094-4802

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 28, 2010

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

July 24, 2013

Results First Posted

July 24, 2013

Record last verified: 2013-06