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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00766675
First received: October 3, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Pain
Fibromyalgia
Drug: Tramadol hydrochloride
Drug: Acetaminophen
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • Pain Visual Analog Scale Score at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14, 28 and 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14, 28 and 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14, 28 and 56 ] [ Designated as safety issue: No ]
    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.


Enrollment: 80
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol hydrochloride/acetaminophen
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.
Drug: Tramadol hydrochloride
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.
Drug: Acetaminophen
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766675

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan Ltd Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00766675     History of Changes
Other Study ID Numbers: CR015319, TRAMMAPPAI4033
Study First Received: October 3, 2008
Results First Received: February 18, 2013
Last Updated: May 29, 2013
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Johnson & Johnson Taiwan Ltd:
Pain
Fibromyalgia
Ultracet
Tramadol Hydrochloride
Acetaminophen

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 20, 2014