Fibromyalgia, Pain
Conditions
Keywords
Pain, Fibromyalgia, Ultracet, Tramadol Hydrochloride, Acetaminophen
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.
Interventions
DRUGTramadol 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.
DRUGAcetaminophen
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.
Sponsors
Johnson & Johnson Taiwan Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale Score at Day 14 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessment Sleep Questionnaire Score | Baseline and Day 56 | 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 | Baseline and Day 56 | 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 Categorical Scores on Pain Relief Rating Scale | Day 14, 28 and 56 | 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. |
| Number of Participants With Subject's Global Assessment | Day 14, 28 and 56 | 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. |
| Number of Participants With Physician Global Assessment | Day 14, 28 and 56 | 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. |
| Tender-Point Evaluation/ Myalgic Score | Baseline and Day 56 | 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 | Baseline and Day 56 | 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 flow
Participants by arm
| Arm | Count |
|---|---|
| Tramadol Hydrochloride/Acetaminophen Tramadol hydrochloride/acetaminophen oral tablet was 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. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Insufficient therapy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Participant took prohibited medication | 1 |
| Overall Study | Protocol Violation | 8 |
| Overall Study | Receive other anti-neoplastic treatment | 1 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Tramadol Hydrochloride/Acetaminophen |
|---|---|
| Age Continuous | 50.4 Years STANDARD_DEVIATION 10.01 |
| Pain Visual Analog Scale at Baseline | 71.3 Units on a scale STANDARD_DEVIATION 18.22 |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 80 |
| serious Total, serious adverse events | 2 / 80 |
Outcome results
Primary
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).
Time frame: Day 14
Population: Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Pain Visual Analog Scale Score at Day 14 | 53.0 Millimeter (mm) | Standard Deviation 20.12 |
Primary
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).
Time frame: Day 28
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Pain Visual Analog Scale Score at Day 28 | 49.6 Millimeter (mm) | Standard Deviation 20.95 |
Primary
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).
Time frame: Day 56
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Pain Visual Analog Scale Score at Day 56 | 44.9 Millimeter (mm) | Standard Deviation 20.95 |
Secondary
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.
Time frame: Day 14, 28 and 56
Population: The ITT population included all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | A lot:Day 14 | 12 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Moderate:Day 14 | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Worse:Day 14 | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Missing:Day 14 | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | A lot:Day 28 | 17 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Moderate:Day 28 | 23 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Slight:Day 28 | 14 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | None:Day 28 | 5 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Worse:Day 28 | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Missing:Day 28 | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | A lot:Day 56 | 25 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Moderate:Day 56 | 13 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Slight:Day 56 | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | None:Day 56 | 9 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Worse:Day 56 | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Missing:Day 56 | 12 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | Slight:Day 14 | 24 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Categorical Scores on Pain Relief Rating Scale | None:Day 14 | 4 Participants |
Secondary
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.
Time frame: Day 14, 28 and 56
Population: The ITT population included all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very poor (Day 14) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very good (Day 28) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very good (Day 28) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Good (Day 28) | 23 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Good (Day 56) | 22 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Moderate (Day 56) | 13 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Poor (Day 56) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very poor (Day 56) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Missing (Day 56) | 28 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very good (Day 56) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Good (Day 56) | 26 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Moderate (Day 56) | 15 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Poor (Day 56) | 6 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very poor (Day 56) | 1 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Missing (Day 56) | 28 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Good (Day 14) | 23 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very good (Day 14) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Good (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Moderate (Day 14) | 30 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Poor (Day 14) | 10 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very good (Day 14) | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Moderate (Day 14) | 14 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Poor (Day 14) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very poor (Day 14) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very good (Day 14) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Good (Day 14) | 14 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Moderate (Day 14) | 34 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Poor (Day 14) | 10 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very poor (Day 14) | 1 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Good (Day 28) | 20 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Moderate (Day 28) | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Poor (Day 28) | 7 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very poor (Day 28) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very good (Day 28) | 14 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Good (Day 28) | 22 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Moderate (Day 28) | 11 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Poor (Day 28) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very poor (Day 28) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Moderate (Day 28) | 17 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Poor (Day 28) | 6 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Very poor (Day 28) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q3: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very good (Day 56) | 5 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Good (Day 56) | 20 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Moderate (Day 56) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Poor (Day 56) | 8 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Very poor (Day 56) | 1 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q1: Missing (Day 56) | 28 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Physician Global Assessment | Q2: Very good (Day 56) | 13 Participants |
Secondary
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.
Time frame: Day 14, 28 and 56
Population: The ITT population included all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very poor (Day 28) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very good (Day 56) | 14 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Good (Day 56) | 21 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very good (Day 14) | 5 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Good (Day 14) | 8 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Moderate (Day 14) | 32 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Poor (Day 14) | 15 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very poor (Day 14) | 2 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very good (Day 14) | 16 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Good (Day 14) | 21 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Moderate (Day 14) | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Poor (Day 14) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very poor (Day 14) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very good (Day 14) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Good (Day 14) | 8 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Moderate (Day 14) | 38 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Poor (Day 14) | 13 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very poor (Day 14) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Missing (Day 14) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very good (Day 28) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Good (Day 28) | 15 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Moderate (Day 28) | 21 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Poor (Day 28) | 7 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very poor (Day 28) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very good (Day 28) | 16 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Good (Day 28) | 16 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Moderate (Day 28) | 13 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Poor (Day 28) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very poor (Day 28) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very good (Day 28) | 3 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Good (Day 28) | 17 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Moderate (Day 28) | 21 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Poor (Day 28) | 8 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Missing (Day 28) | 31 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very good (Day 56) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Good (Day 56) | 18 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Moderate (Day 56) | 19 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Poor (Day 56) | 10 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Very poor (Day 56) | 1 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q1: Missing (Day 56) | 28 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Moderate (Day 56) | 9 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Poor (Day 56) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Very poor (Day 56) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q2: Missing (Day 56) | 28 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very good (Day 56) | 4 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Good (Day 56) | 16 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Moderate (Day 56) | 25 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Poor (Day 56) | 7 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Very poor (Day 56) | 0 Participants |
| Tramadol Hydrochloride/Acetaminophen | Number of Participants With Subject's Global Assessment | Q3: Missing (Day 56) | 28 Participants |
Secondary
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.
Time frame: Baseline and Day 56
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 9: Day 56 | 4.4 Units on a scale | Standard Deviation 1.4 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 3: Baseline | 2.5 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 4: Baseline | 4.5 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 5: Baseline | 3.8 Units on a scale | Standard Deviation 1.6 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 6: Baseline | 2.9 Units on a scale | Standard Deviation 1.5 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 7: Baseline | 2.9 Units on a scale | Standard Deviation 1.6 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 8: Baseline | 2.9 Units on a scale | Standard Deviation 1.5 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 9: Baseline | 3.5 Units on a scale | Standard Deviation 1.6 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 10: Baseline | 3.4 Units on a scale | Standard Deviation 1.5 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 11: Baseline | 3.3 Units on a scale | Standard Deviation 1.7 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 12: Baseline | 4.7 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 3: Day 56 | 3.8 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 4: Day 56 | 3.5 Units on a scale | Standard Deviation 1.4 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 5: Day 56 | 4.9 Units on a scale | Standard Deviation 1.1 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 6: Day 56 | 4.3 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 7: Day 56 | 4.2 Units on a scale | Standard Deviation 1.5 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 8: Day 56 | 4.4 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 10: Day 56 | 4.6 Units on a scale | Standard Deviation 1.1 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 11: Day 56 | 4.2 Units on a scale | Standard Deviation 1.4 |
| Tramadol Hydrochloride/Acetaminophen | Participant Assessment Sleep Questionnaire Score | Question 12: Day 56 | 3.8 Units on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: Baseline and Day 56
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | Question 2: Baseline | 5.4 Hours | Standard Deviation 1.5 |
| Tramadol Hydrochloride/Acetaminophen | Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | Question 1: Baseline | 3.2 Hours | Standard Deviation 1.3 |
| Tramadol Hydrochloride/Acetaminophen | Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | Question 1: Day 56 | 2.2 Hours | Standard Deviation 1.2 |
| Tramadol Hydrochloride/Acetaminophen | Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept | Question 2: Day 56 | 6.4 Hours | Standard Deviation 1.3 |
Secondary
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.
Time frame: Baseline and Day 56
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Tender-Point Evaluation (right side):Baseline | 7.9 Units on a scale | Standard Deviation 1.2 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Myalgic Score (right side):Baseline | 13.6 Units on a scale | Standard Deviation 4 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Tender-Point Evaluation (left side):Baseline | 7.8 Units on a scale | Standard Deviation 1.2 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Myalgic Score (left side):Baseline | 13.1 Units on a scale | Standard Deviation 4.1 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Tender-Point Evaluation (right side):Day 56 | 4.9 Units on a scale | Standard Deviation 2.5 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Myalgic Score (right side):Day 56 | 7.0 Units on a scale | Standard Deviation 5.3 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Tender-Point Evaluation (left side):Day 56 | 5.1 Units on a scale | Standard Deviation 2.4 |
| Tramadol Hydrochloride/Acetaminophen | Tender-Point Evaluation/ Myalgic Score | Myalgic Score (left side):Day 56 | 7.2 Units on a scale | Standard Deviation 5.2 |
Secondary
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.
Time frame: Baseline and Day 56
Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen | Total Fibromyalgia Impact Questionnaire (FIQ) Score | Baseline (n=73) | 6.1 Units on a scale | Standard Deviation 1.55 |
| Tramadol Hydrochloride/Acetaminophen | Total Fibromyalgia Impact Questionnaire (FIQ) Score | Day 56 (n=51) | 4.0 Units on a scale | Standard Deviation 1.94 |