PainPhase 4NCT00766675
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
A Phase 4 study testing Tramadol hydrochloride and Acetaminophen in people with Pain and Fibromyalgia, run by Johnson & Johnson Taiwan Ltd.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pain, Fibromyalgia
- What is being tested?
- Tramadol hydrochloride and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
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).
Read the 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.
- Conditions
- Pain, Fibromyalgia
- Being tested
- Tramadol hydrochloride, Acetaminophen
- Keywords
- Pain, Fibromyalgia, Ultracet, Tramadol Hydrochloride, Acetaminophen
- Medical subject headings
- Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochlorideDrug
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.
AcetaminophenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol hydrochloride/acetaminophen | Experimental | 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. Receives: Drug: Tramadol hydrochloride; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)".
Measured: Day 14
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)".
Measured: Day 28
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)".
Measured: Day 56
Secondary outcomes (7)
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.
Measured: Day 14, 28 and 56
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.
Measured: Baseline and Day 56
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".
Measured: Baseline and Day 56
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.
Measured: Baseline and Day 56
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.
Measured: Baseline and Day 56
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.
Measured: Day 14, 28 and 56
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.
Measured: Day 14, 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan Ltd Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766675
- Sponsor's protocol ID
- CR015319
- Other IDs
- TRAMMAPPAI4033
- Status last verified
- May 2013
- First submitted
- 3 Oct 2008
- Last updated
- 3 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00766675
- Acronym / sponsor ID
- CR015319
- Conditions
- Pain, Fibromyalgia
- Keywords
- Pain, Fibromyalgia, Ultracet, Tramadol Hydrochloride, Acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Posted 3 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tramadol hydrochloride/acetaminophen | Experimental | Drug: Tramadol hydrochloride, Drug: AcetaminophenTramadol 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol hydrochlorideTramadol 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 | Tramadol hydrochloride/acetaminophen |
| AcetaminophenAcetaminophen 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. | Drug | Tramadol hydrochloride/acetaminophen |
Primary outcome
Pain Visual Analog Scale Score at Day 14
Time frame: 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
Time frame: 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
Time frame: 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)".
7 secondary outcomes
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Time frame: Day 14, 28 and 56
Tender-Point Evaluation/ Myalgic Score
Time frame: Baseline and Day 56
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Time frame: Baseline and Day 56
Participant Assessment Sleep Questionnaire Score
Time frame: Baseline and Day 56
Total Fibromyalgia Impact Questionnaire (FIQ) Score
Time frame: Baseline and Day 56
Number of Participants With Physician Global Assessment
Time frame: Day 14, 28 and 56
Number of Participants With Subject's Global Assessment
Time frame: Day 14, 28 and 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Taiwan Ltd Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol hydrochloride and Acetaminophen in people with Pain and Fibromyalgia, run by Johnson & Johnson Taiwan Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale Score at Day 14 (time frame: Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.