Trial Outcomes & Findings for An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain (NCT NCT00766675)
NCT ID: NCT00766675
Last Updated: 2013-07-03
Results Overview
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)".
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Day 14
Results posted on
2013-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Participant took prohibited medication
|
1
|
|
Overall Study
Receive other anti-neoplastic treatment
|
1
|
|
Overall Study
Insufficient therapy
|
1
|
Baseline Characteristics
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Baseline characteristics by cohort
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 Participants
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.
|
|---|---|
|
Age Continuous
|
50.4 Years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Pain Visual Analog Scale at Baseline
|
71.3 Units on a scale
STANDARD_DEVIATION 18.22 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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)".
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=73 Participants
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.
|
|---|---|
|
Pain Visual Analog Scale Score at Day 14
|
53.0 Millimeter (mm)
Standard Deviation 20.12
|
PRIMARY outcome
Timeframe: Day 28Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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)".
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=73 Participants
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.
|
|---|---|
|
Pain Visual Analog Scale Score at Day 28
|
49.6 Millimeter (mm)
Standard Deviation 20.95
|
PRIMARY outcome
Timeframe: Day 56Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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)".
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=73 Participants
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.
|
|---|---|
|
Pain Visual Analog Scale Score at Day 56
|
44.9 Millimeter (mm)
Standard Deviation 20.95
|
SECONDARY outcome
Timeframe: Day 14, 28 and 56Population: The ITT population included all enrolled participants.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 Participants
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.
|
|---|---|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
A lot:Day 14
|
12 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Moderate:Day 14
|
19 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Slight:Day 14
|
24 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
None:Day 14
|
4 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Worse:Day 14
|
2 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Missing:Day 14
|
19 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
A lot:Day 28
|
17 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Moderate:Day 28
|
23 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Slight:Day 28
|
14 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
None:Day 28
|
5 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Worse:Day 28
|
3 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Missing:Day 28
|
18 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
A lot:Day 56
|
25 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Moderate:Day 56
|
13 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Slight:Day 56
|
18 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
None:Day 56
|
9 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Worse:Day 56
|
3 Participants
|
|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Missing:Day 56
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=51 Participants
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.
|
|---|---|
|
Tender-Point Evaluation/ Myalgic Score
Tender-Point Evaluation (right side):Baseline
|
7.9 Units on a scale
Standard Deviation 1.2
|
|
Tender-Point Evaluation/ Myalgic Score
Myalgic Score (right side):Baseline
|
13.6 Units on a scale
Standard Deviation 4.0
|
|
Tender-Point Evaluation/ Myalgic Score
Tender-Point Evaluation (left side):Baseline
|
7.8 Units on a scale
Standard Deviation 1.2
|
|
Tender-Point Evaluation/ Myalgic Score
Myalgic Score (left side):Baseline
|
13.1 Units on a scale
Standard Deviation 4.1
|
|
Tender-Point Evaluation/ Myalgic Score
Tender-Point Evaluation (right side):Day 56
|
4.9 Units on a scale
Standard Deviation 2.5
|
|
Tender-Point Evaluation/ Myalgic Score
Myalgic Score (right side):Day 56
|
7.0 Units on a scale
Standard Deviation 5.3
|
|
Tender-Point Evaluation/ Myalgic Score
Tender-Point Evaluation (left side):Day 56
|
5.1 Units on a scale
Standard Deviation 2.4
|
|
Tender-Point Evaluation/ Myalgic Score
Myalgic Score (left side):Day 56
|
7.2 Units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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".
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=51 Participants
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.
|
|---|---|
|
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Question 1: Baseline
|
3.2 Hours
Standard Deviation 1.3
|
|
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Question 2: Baseline
|
5.4 Hours
Standard Deviation 1.5
|
|
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Question 1: Day 56
|
2.2 Hours
Standard Deviation 1.2
|
|
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Question 2: Day 56
|
6.4 Hours
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=51 Participants
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.
|
|---|---|
|
Participant Assessment Sleep Questionnaire Score
Question 3: Baseline
|
2.5 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 4: Baseline
|
4.5 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 5: Baseline
|
3.8 Units on a scale
Standard Deviation 1.6
|
|
Participant Assessment Sleep Questionnaire Score
Question 6: Baseline
|
2.9 Units on a scale
Standard Deviation 1.5
|
|
Participant Assessment Sleep Questionnaire Score
Question 7: Baseline
|
2.9 Units on a scale
Standard Deviation 1.6
|
|
Participant Assessment Sleep Questionnaire Score
Question 8: Baseline
|
2.9 Units on a scale
Standard Deviation 1.5
|
|
Participant Assessment Sleep Questionnaire Score
Question 9: Baseline
|
3.5 Units on a scale
Standard Deviation 1.6
|
|
Participant Assessment Sleep Questionnaire Score
Question 10: Baseline
|
3.4 Units on a scale
Standard Deviation 1.5
|
|
Participant Assessment Sleep Questionnaire Score
Question 11: Baseline
|
3.3 Units on a scale
Standard Deviation 1.7
|
|
Participant Assessment Sleep Questionnaire Score
Question 12: Baseline
|
4.7 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 3: Day 56
|
3.8 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 4: Day 56
|
3.5 Units on a scale
Standard Deviation 1.4
|
|
Participant Assessment Sleep Questionnaire Score
Question 5: Day 56
|
4.9 Units on a scale
Standard Deviation 1.1
|
|
Participant Assessment Sleep Questionnaire Score
Question 6: Day 56
|
4.3 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 7: Day 56
|
4.2 Units on a scale
Standard Deviation 1.5
|
|
Participant Assessment Sleep Questionnaire Score
Question 8: Day 56
|
4.4 Units on a scale
Standard Deviation 1.3
|
|
Participant Assessment Sleep Questionnaire Score
Question 9: Day 56
|
4.4 Units on a scale
Standard Deviation 1.4
|
|
Participant Assessment Sleep Questionnaire Score
Question 10: Day 56
|
4.6 Units on a scale
Standard Deviation 1.1
|
|
Participant Assessment Sleep Questionnaire Score
Question 11: Day 56
|
4.2 Units on a scale
Standard Deviation 1.4
|
|
Participant Assessment Sleep Questionnaire Score
Question 12: Day 56
|
3.8 Units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: 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.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=73 Participants
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.
|
|---|---|
|
Total Fibromyalgia Impact Questionnaire (FIQ) Score
Baseline (n=73)
|
6.1 Units on a scale
Standard Deviation 1.55
|
|
Total Fibromyalgia Impact Questionnaire (FIQ) Score
Day 56 (n=51)
|
4.0 Units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Day 14, 28 and 56Population: The ITT population included all enrolled participants.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 Participants
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.
|
|---|---|
|
Number of Participants With Physician Global Assessment
Q1: Poor (Day 28)
|
7 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very poor (Day 28)
|
0 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very good (Day 28)
|
14 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Good (Day 28)
|
22 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very good (Day 14)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Good (Day 14)
|
18 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Moderate (Day 14)
|
30 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Poor (Day 14)
|
10 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very poor (Day 14)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very good (Day 14)
|
19 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Good (Day 14)
|
23 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Moderate (Day 14)
|
14 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Poor (Day 14)
|
4 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very poor (Day 14)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very good (Day 14)
|
3 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Good (Day 14)
|
14 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Moderate (Day 14)
|
34 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Poor (Day 14)
|
10 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very poor (Day 14)
|
1 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very good (Day 28)
|
3 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Good (Day 28)
|
20 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Moderate (Day 28)
|
19 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Moderate (Day 28)
|
11 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Poor (Day 28)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very poor (Day 28)
|
0 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very good (Day 28)
|
3 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Good (Day 28)
|
23 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Moderate (Day 28)
|
17 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Poor (Day 28)
|
6 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very poor (Day 28)
|
0 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very good (Day 56)
|
5 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Good (Day 56)
|
20 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Moderate (Day 56)
|
18 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Poor (Day 56)
|
8 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Very poor (Day 56)
|
1 Participants
|
|
Number of Participants With Physician Global Assessment
Q1: Missing (Day 56)
|
28 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very good (Day 56)
|
13 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Good (Day 56)
|
22 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Moderate (Day 56)
|
13 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Poor (Day 56)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Very poor (Day 56)
|
2 Participants
|
|
Number of Participants With Physician Global Assessment
Q2: Missing (Day 56)
|
28 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very good (Day 56)
|
4 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Good (Day 56)
|
26 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Moderate (Day 56)
|
15 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Poor (Day 56)
|
6 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Very poor (Day 56)
|
1 Participants
|
|
Number of Participants With Physician Global Assessment
Q3: Missing (Day 56)
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 14, 28 and 56Population: The ITT population included all enrolled participants.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 Participants
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.
|
|---|---|
|
Number of Participants With Subject's Global Assessment
Q1: Very good (Day 14)
|
5 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Good (Day 14)
|
8 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Moderate (Day 14)
|
32 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Poor (Day 14)
|
15 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Very poor (Day 14)
|
2 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very good (Day 14)
|
16 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Good (Day 14)
|
21 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Moderate (Day 14)
|
19 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Poor (Day 14)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very poor (Day 14)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very good (Day 14)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Good (Day 14)
|
8 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Moderate (Day 14)
|
38 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Poor (Day 14)
|
13 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very poor (Day 14)
|
0 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Missing (Day 14)
|
18 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Very good (Day 28)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Good (Day 28)
|
15 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Moderate (Day 28)
|
21 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Poor (Day 28)
|
7 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Very poor (Day 28)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very good (Day 28)
|
16 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Good (Day 28)
|
16 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Moderate (Day 28)
|
13 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Poor (Day 28)
|
4 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very poor (Day 28)
|
0 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very good (Day 28)
|
3 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Good (Day 28)
|
17 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Moderate (Day 28)
|
21 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Poor (Day 28)
|
8 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very poor (Day 28)
|
0 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Missing (Day 28)
|
31 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Very good (Day 56)
|
4 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Good (Day 56)
|
18 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Moderate (Day 56)
|
19 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Poor (Day 56)
|
10 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Very poor (Day 56)
|
1 Participants
|
|
Number of Participants With Subject's Global Assessment
Q1: Missing (Day 56)
|
28 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very good (Day 56)
|
14 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Good (Day 56)
|
21 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Moderate (Day 56)
|
9 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Poor (Day 56)
|
4 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Very poor (Day 56)
|
4 Participants
|
|
Number of Participants With Subject's Global Assessment
Q2: Missing (Day 56)
|
28 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very good (Day 56)
|
4 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Good (Day 56)
|
16 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Moderate (Day 56)
|
25 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Poor (Day 56)
|
7 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Very poor (Day 56)
|
0 Participants
|
|
Number of Participants With Subject's Global Assessment
Q3: Missing (Day 56)
|
28 Participants
|
Adverse Events
Tramadol Hydrochloride/Acetaminophen
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Other adverse events
| Measure |
Tramadol Hydrochloride/Acetaminophen
n=80 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Palpitations
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
4/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
12/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Nausea
|
11.2%
9/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
5/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Asthenia
|
3.8%
3/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Chest pain
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Malaise
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Pain
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Immune system disorders
Dermatomyositis
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Immune system disorders
Drug eruption
|
3.8%
3/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Gout
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
17.5%
14/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Vertigo
|
5.0%
4/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Akathisia
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Anorexia
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Decreased appetite
|
2.5%
2/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Somnolence
|
6.2%
5/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
4/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Vascular disorders
Ecchymosis
|
1.2%
1/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoviral upper respiratory
|
3.8%
3/80 • Baseline up to Day 56
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Additional Information
Medical Affairs Director
Janssen Pharmaceutics Taiwan
Phone: +886-2-23762155
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60