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An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tramadol HCl/acetaminophen Extended Release
Placebo
Tramadol HCl/acetaminophen Extended Release
Placebo
Sponsored by
Janssen Korea, Ltd., Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic low back pain, Tramadol Hydrochloride (HCl), acetaminophen

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tramadol Hydrochloride (HCl)/acetaminophen

    Placebo

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Percentage of Participants With Pain Relief
    Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.
    Change From Baseline in Short Form (SF)-36 Score at Day 29
    The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in "Reported (Rptd.) Health Transition" domain higher score indicates worse quality of life.
    Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
    The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.
    Percentage of Participants With Investigator's Global Assessment on Investigational Product
    Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
    Percentage of Participants With Participants' Global Assessment on Investigational Product
    Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.

    Full Information

    First Posted
    April 1, 2010
    Last Updated
    June 20, 2013
    Sponsor
    Janssen Korea, Ltd., Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01112267
    Brief Title
    An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
    Official Title
    A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Korea, Ltd., Korea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This is a double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), placebo-controlled, parallel group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) and up-titration study in participants with chronic low back pain. The study will consist of 6 visits (Day -7 to Day -1 [Visit 1], Day 1 [Visit 2], Day 3 [telephone visit], Day 8 [Visit 3], Day 15 [Visit 4] and Day 29 [Visit 5]) and 2 phases: a screening phase and treatment phase. Screening phase will be of 7 days during which, participants will receive stable dose of non-steroidal anti-inflammatory drugs (NSAIDS) or COX-2 selective inhibitors (NSAID that specifically inhibits an enzyme known as cyclooxygenase-2) for pain therapy. On the basis of average pain intensity over the last 48 hours which will be measured at baseline (at the end of screening period), participants will enter the treatment phase. Treatment phase will be of 28 days which includes 7-days of dose titration period. In treatment phase all participants will be randomly assigned to 1 of 2 possible treatments: tramadol HCl 75 milligram (mg)/acetaminophen 650 mg ER tablet treatment or the equivalent placebo (an inactive substance) treatment until study completion, Day 29. Participants will receive 1 tablet of tramadol HCl/acetaminophen ER or its equivalent placebo, once daily for 3 days. After the first 3 days, the participants will receive a telephone inquiry monitoring the occurrence of adverse events and will be given additional administration instructions for the next 4 days (1 tablet twice daily for 4 days). From Day 7, participants will receive 1 or 2 tablets twice a day depending on the degree of pain relief required. Participants will visit the center on the Day 8 (Visit 3), Day 15 (Visit 4), and Day 29 (Visit 5) after starting study drug. The efficacy will be assessed by measuring extent of reduction in pain intensity on a Visual Analog Scale (VAS). 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
    Keywords
    Chronic low back pain, Tramadol Hydrochloride (HCl), acetaminophen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    248 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol Hydrochloride (HCl)/acetaminophen
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol HCl/acetaminophen Extended Release
    Other Intervention Name(s)
    Ultracet Extended Relaese
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol HCl/acetaminophen Extended Release
    Other Intervention Name(s)
    Ultracet Extended Relaese
    Intervention Description
    Participants will receive 1 or 2 tablets containing 75 mg of tramadol HCl and 650 mg of acetaminophen, twice daily on Days 8 to 28
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Prticipants will receive 1 or 2 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 8 to 28
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Reduction in Pain Intensity
    Description
    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.
    Time Frame
    Baseline up to Day 29
    Title
    Change From Baseline in Pain Intensity at Day 29
    Description
    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.
    Time Frame
    Baseline and Day 29
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Pain Relief
    Description
    Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.
    Time Frame
    Day 8, Day 15 and Day 29
    Title
    Change From Baseline in Short Form (SF)-36 Score at Day 29
    Description
    The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in "Reported (Rptd.) Health Transition" domain higher score indicates worse quality of life.
    Time Frame
    Baseline and Day 29
    Title
    Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
    Description
    The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.
    Time Frame
    Baseline and Day 29
    Title
    Percentage of Participants With Investigator's Global Assessment on Investigational Product
    Description
    Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
    Time Frame
    Day 29
    Title
    Percentage of Participants With Participants' Global Assessment on Investigational Product
    Description
    Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
    Time Frame
    Day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Korea, Ltd. Clinical Trial
    Organizational Affiliation
    Janssen Korea, Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24183364
    Citation
    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.
    Results Reference
    derived

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    An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain

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