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An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain

Primary Purpose

Pain, Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tramadol hydrochloride
Acetaminophen
Sponsored by
Johnson & Johnson Taiwan Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Fibromyalgia, Ultracet, Tramadol Hydrochloride, Acetaminophen

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain [pain in three quadrants and in the axial skeleton] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites
  • Female participants must not be pregnant, breast feeding or postmenopausal for at least one year
  • Participant must be able to take oral medication
  • Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter
  • Fail to non-opioid analgesics

Exclusion Criteria:

  • Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events
  • Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
  • Participants who currently have more severe pain than the pain of fibromyalgia
  • Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
  • Participants who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tramadol hydrochloride/acetaminophen

    Arm Description

    Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.

    Outcomes

    Primary Outcome Measures

    Pain Visual Analog Scale Score at Day 14
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
    Pain Visual Analog Scale Score at Day 28
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
    Pain Visual Analog Scale Score at Day 56
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".

    Secondary Outcome Measures

    Number of Participants With Categorical Scores on Pain Relief Rating Scale
    Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.
    Tender-Point Evaluation/ Myalgic Score
    Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.
    Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
    The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was "How long did it usually take for participant to fall asleep during the past 4 weeks" and Q2 was "On the average, how many hours did participant sleep each night during the past 4 weeks".
    Participant Assessment Sleep Questionnaire Score
    Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to "How often during past 4 weeks did participant felt" and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.
    Total Fibromyalgia Impact Questionnaire (FIQ) Score
    The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.
    Number of Participants With Physician Global Assessment
    The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.
    Number of Participants With Subject's Global Assessment
    Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.

    Full Information

    First Posted
    October 3, 2008
    Last Updated
    May 29, 2013
    Sponsor
    Johnson & Johnson Taiwan Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00766675
    Brief Title
    An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
    Official Title
    Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    April 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 this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).
    Detailed Description
    This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. 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
    Pain, Fibromyalgia
    Keywords
    Pain, Fibromyalgia, Ultracet, Tramadol Hydrochloride, Acetaminophen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol hydrochloride/acetaminophen
    Arm Type
    Experimental
    Arm Description
    Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol hydrochloride
    Intervention Description
    Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
    Intervention Type
    Drug
    Intervention Name(s)
    Acetaminophen
    Intervention Description
    Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
    Primary Outcome Measure Information:
    Title
    Pain Visual Analog Scale Score at Day 14
    Description
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
    Time Frame
    Day 14
    Title
    Pain Visual Analog Scale Score at Day 28
    Description
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
    Time Frame
    Day 28
    Title
    Pain Visual Analog Scale Score at Day 56
    Description
    Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
    Time Frame
    Day 56
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Categorical Scores on Pain Relief Rating Scale
    Description
    Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.
    Time Frame
    Day 14, 28 and 56
    Title
    Tender-Point Evaluation/ Myalgic Score
    Description
    Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.
    Time Frame
    Baseline and Day 56
    Title
    Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
    Description
    The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was "How long did it usually take for participant to fall asleep during the past 4 weeks" and Q2 was "On the average, how many hours did participant sleep each night during the past 4 weeks".
    Time Frame
    Baseline and Day 56
    Title
    Participant Assessment Sleep Questionnaire Score
    Description
    Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to "How often during past 4 weeks did participant felt" and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.
    Time Frame
    Baseline and Day 56
    Title
    Total Fibromyalgia Impact Questionnaire (FIQ) Score
    Description
    The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.
    Time Frame
    Baseline and Day 56
    Title
    Number of Participants With Physician Global Assessment
    Description
    The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.
    Time Frame
    Day 14, 28 and 56
    Title
    Number of Participants With Subject's Global Assessment
    Description
    Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.
    Time Frame
    Day 14, 28 and 56

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain [pain in three quadrants and in the axial skeleton] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites Female participants must not be pregnant, breast feeding or postmenopausal for at least one year Participant must be able to take oral medication Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter Fail to non-opioid analgesics Exclusion Criteria: Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease Participants who currently have more severe pain than the pain of fibromyalgia Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase Participants who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase
    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 Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain

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