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An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)

Primary Purpose

Spondylitis, Ankylosing, Pain

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tramadol /acetaminophen
Diclofenac
Sponsored by
Johnson & Johnson Taiwan Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing focused on measuring Spondylitis, ankylosing, Pain, Ultracet, Diclofenac, Voltaren, Tramadol/acetaminophen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of ankylosing spondylitis (AS), as defined by Modified New York Criteria for ankylosing spondylitis: a) Low-back pain of at least 3 months duration improved by exercise and not relieved by rest b) Limitation of lumbar spine in sagittal and frontal planes c) Chest expansion decreased relative to normal values for age and sex d) Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke)
  • Participants are suffering from pain, with visual analogue scale (VAS) pain score greater than or equal to (>=) 40 millimeter (mm)
  • Participants are receiving disease modifying anti-rheumatic drugs (DMARDs), which have reached to the stable dosage within 4 weeks prior to the randomization visit - Serum creatinine less than or equal to (<=) 1.2 milligram per deciliter (mg/dL)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 times the laboratory's upper limit of normal
  • Exclusion Criteria:
  • Had an inadequate response to tramadol hydrochloride (HCl) therapy, or have discontinued tramadol HCl therapy due to adverse events
  • Have taken tramadol HCl within 4 weeks prior to the entry of the study
  • Have taken other medications for pain relief within 4 weeks prior to the entry of the study, except rescue medications
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
  • Women with pregnancy or breast-feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tramadol/Acetaminophen

    Diclofenac

    Arm Description

    Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.

    Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 2
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.
    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 4
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.
    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 8
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.

    Secondary Outcome Measures

    Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total and Sub-scale Scores at Week 2, 4, 8
    The BASFI is a self-assessment instrument used to assess function. It comprises of 8 specific questions regarding function in ankylosing spondylitis and 2 questions to identify participant's ability to cope up with everyday life. Each question is answered on a 100 millimeter (mm) horizontal VAS. The mean of VAS score gives BASFI score between 0 to 100 where 0=easy to 100=impossible.
    Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total and Sub-scale Scores at Week 2, 4, 8
    The BASDAI comprises of 6 questions pertaining to 5 major symptoms of ankylosing spondylitis: a) fatigue; b) spinal pain; c) peripheral arthritis; d) enthesopathy; and e) morning stiffness. It is used to measure disease activity. It consists of VAS ranging from 0 to 100 where 0 = no problem and 100 = worst problem. To give each symptom equal weightage, the mean (average) of two scores relating to morning stiffness is taken. The resulting 0 to 500 is divided by 5 to get BASDAI score between 0 to 100 (0 = no problem and 100 = worst problem).
    Quality of Life Medical outcome Study Health Survey Short Form 36 (QoL-SF36) Total and Sub-scale Scores
    The QoL-SF36 is a general health questionnaire that comprises of physical function, social function, and the participants' perception of general health, well-being and satisfaction with the treatment .
    Number of Participants with Adverse Event (AEs) and Serious Adverse Events (SAEs)
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Full Information

    First Posted
    October 3, 2008
    Last Updated
    October 14, 2014
    Sponsor
    Johnson & Johnson Taiwan Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00766402
    Brief Title
    An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
    Official Title
    A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Taiwan Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram [mg]) in the treatment of pain in participants with ankylosing spondylitis (inflammation of the spine causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).
    Detailed Description
    This is a single center, open labeled (all people know the identity of intervention), randomized (study drug assigned by chance), parallel group (a medical research study comparing the response in two or more groups of participants receiving different interventions (treatments) trial to compare the effectiveness (pain relief) and safety of tramadol 37.5 mg and acetaminophen 325 mg with diclofenac in participants with ankylosing spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs). Participants who meet the eligibility criteria will be randomized to one of the two treatment groups (tramadol/acetaminophen and Diclofenac). One group will be treated with tramadol 37.5 mg/acetaminophen 325 mg combination tablet and another group will be treated with diclofenac 50 mg tablet. Participants randomized into this study will be instructed to take one tablet Ultracet or diclofenac 50 mg orally, twice a day for 8 weeks. Evaluations will be performed as outlined: at Screening, at Baseline, and at Weeks 2, 4, and 8. The primary efficacy parameter is to compare the mean change from Baseline in visual analogue scale (VAS) pain score between the two treatment groups (tramadol/acetaminophen versus diclofenac). 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
    Spondylitis, Ankylosing, Pain
    Keywords
    Spondylitis, ankylosing, Pain, Ultracet, Diclofenac, Voltaren, Tramadol/acetaminophen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol/Acetaminophen
    Arm Type
    Experimental
    Arm Description
    Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.
    Arm Title
    Diclofenac
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol /acetaminophen
    Other Intervention Name(s)
    Ultracet®
    Intervention Description
    Participants will receive a combination tablet of 37.5 milligram (mg) tramadol and 325 mg acetaminophen, orally twice daily up to 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac
    Other Intervention Name(s)
    Voltaren®
    Intervention Description
    Participants will receive 50 mg diclofenac tablet, orally twice daily up to 8 weeks.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 2
    Description
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 4
    Description
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in Visual Analogue Scale (VAS) Score at Week 8
    Description
    Visual Analogue Scale (VAS) is a pain rating scale. The range of VAS score is from 0 to 10 where 0 = no pain and 10 = unbearable pain.
    Time Frame
    Baseline and Week 8
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total and Sub-scale Scores at Week 2, 4, 8
    Description
    The BASFI is a self-assessment instrument used to assess function. It comprises of 8 specific questions regarding function in ankylosing spondylitis and 2 questions to identify participant's ability to cope up with everyday life. Each question is answered on a 100 millimeter (mm) horizontal VAS. The mean of VAS score gives BASFI score between 0 to 100 where 0=easy to 100=impossible.
    Time Frame
    Baseline and Week 2, 4 and 8
    Title
    Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total and Sub-scale Scores at Week 2, 4, 8
    Description
    The BASDAI comprises of 6 questions pertaining to 5 major symptoms of ankylosing spondylitis: a) fatigue; b) spinal pain; c) peripheral arthritis; d) enthesopathy; and e) morning stiffness. It is used to measure disease activity. It consists of VAS ranging from 0 to 100 where 0 = no problem and 100 = worst problem. To give each symptom equal weightage, the mean (average) of two scores relating to morning stiffness is taken. The resulting 0 to 500 is divided by 5 to get BASDAI score between 0 to 100 (0 = no problem and 100 = worst problem).
    Time Frame
    Baseline, Week 2, 4 and 8
    Title
    Quality of Life Medical outcome Study Health Survey Short Form 36 (QoL-SF36) Total and Sub-scale Scores
    Description
    The QoL-SF36 is a general health questionnaire that comprises of physical function, social function, and the participants' perception of general health, well-being and satisfaction with the treatment .
    Time Frame
    Baseline and Week 8
    Title
    Number of Participants with Adverse Event (AEs) and Serious Adverse Events (SAEs)
    Description
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    Time Frame
    Week 2 to 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of ankylosing spondylitis (AS), as defined by Modified New York Criteria for ankylosing spondylitis: a) Low-back pain of at least 3 months duration improved by exercise and not relieved by rest b) Limitation of lumbar spine in sagittal and frontal planes c) Chest expansion decreased relative to normal values for age and sex d) Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke) Participants are suffering from pain, with visual analogue scale (VAS) pain score greater than or equal to (>=) 40 millimeter (mm) Participants are receiving disease modifying anti-rheumatic drugs (DMARDs), which have reached to the stable dosage within 4 weeks prior to the randomization visit - Serum creatinine less than or equal to (<=) 1.2 milligram per deciliter (mg/dL) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 times the laboratory's upper limit of normal Exclusion Criteria: Had an inadequate response to tramadol hydrochloride (HCl) therapy, or have discontinued tramadol HCl therapy due to adverse events Have taken tramadol HCl within 4 weeks prior to the entry of the study Have taken other medications for pain relief within 4 weeks prior to the entry of the study, except rescue medications Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders Women with pregnancy or breast-feeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Taiwan, Ltd. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Taiwan Ltd
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)

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