Trial Outcomes & Findings for A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis (NCT NCT00635349)
NCT ID: NCT00635349
Last Updated: 2013-07-22
Results Overview
The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
143 participants
Primary outcome timeframe
Day 29 and Day 85
Results posted on
2013-07-22
Participant Flow
A total of 143 participants were given informed consent, out of which 3 participants had screening failure.
Participant milestones
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
67
|
|
Overall Study
COMPLETED
|
29
|
19
|
|
Overall Study
NOT COMPLETED
|
44
|
48
|
Reasons for withdrawal
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Overall Study
Other
|
8
|
6
|
|
Overall Study
Protocol Violation
|
18
|
22
|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Adverse Event
|
11
|
9
|
Baseline Characteristics
A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=73 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=67 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29 and Day 85Population: Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.
The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
Day 29
|
33.54 units on a scale
Standard Deviation 15.01
|
39.44 units on a scale
Standard Deviation 14.17
|
|
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
Change at Day 85
|
-1.88 units on a scale
Standard Deviation 11.07
|
-0.07 units on a scale
Standard Deviation 13.46
|
SECONDARY outcome
Timeframe: Day 29 and Day 85Population: Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=56 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=52 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Change From Day 29 in Pain Intensity Score at Day 85
Day 29
|
3.82 units on a scale
Standard Deviation 1.22
|
3.81 units on a scale
Standard Deviation 1.03
|
|
Change From Day 29 in Pain Intensity Score at Day 85
Change at Day 85
|
0.14 units on a scale
Standard Deviation 1.76
|
0.83 units on a scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Day 29, Day 57 and Day 85Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Number of Participants With Pain Relief
Day 29; Pain relieved (n=56, 52)
|
49 participants
|
42 participants
|
|
Number of Participants With Pain Relief
Day 57; Pain relieved (n=47, 41)
|
32 participants
|
28 participants
|
|
Number of Participants With Pain Relief
Day 85; Pain relieved (n=55, 56)
|
42 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Day 85Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=57 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=57 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Number of Participants With Overall Assessment on Study Drug by Participants
Very bad
|
1 participants
|
1 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Participants
Bad
|
2 participants
|
11 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Participants
Moderate
|
21 participants
|
22 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Participants
Good
|
29 participants
|
21 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Participants
Very good
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 85Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=57 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=57 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Number of Participants With Overall Assessment on Study Drug by Investigator
Very bad
|
1 participants
|
0 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Investigator
Bad
|
1 participants
|
6 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Investigator
Moderate
|
21 participants
|
25 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Investigator
Good
|
31 participants
|
24 participants
|
|
Number of Participants With Overall Assessment on Study Drug by Investigator
Very good
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 29, Day 57 and Day 85Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Number of Participants With Categorical Swelling
Day 85; PCFF (n=55, 56)
|
1 participants
|
9 participants
|
|
Number of Participants With Categorical Swelling
Day 85; Patellar ballotment (n=55, 56)
|
1 participants
|
1 participants
|
|
Number of Participants With Categorical Swelling
Day 29; No swelling (n=56, 52)
|
52 participants
|
45 participants
|
|
Number of Participants With Categorical Swelling
Day 29; PCFF (n=56, 52)
|
4 participants
|
7 participants
|
|
Number of Participants With Categorical Swelling
Day 57; No swelling (n=47, 41)
|
43 participants
|
38 participants
|
|
Number of Participants With Categorical Swelling
Day 57; PCFF (n=47, 41)
|
4 participants
|
3 participants
|
|
Number of Participants With Categorical Swelling
Day 85; No swelling (n=55, 56)
|
53 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Day 29, Day 57 and Day 85Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.
Outcome measures
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=59 Participants
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Number of Participants With Categorical Tenderness
Day 85; Complaint of tenderness (n=55, 56)
|
15 participants
|
10 participants
|
|
Number of Participants With Categorical Tenderness
Day 29; No tenderness(n=56, 52)
|
33 participants
|
37 participants
|
|
Number of Participants With Categorical Tenderness
Day 29; Complaint of tenderness (n=56, 52)
|
22 participants
|
14 participants
|
|
Number of Participants With Categorical Tenderness
Day 29; CTW (n=56, 52)
|
0 participants
|
1 participants
|
|
Number of Participants With Categorical Tenderness
Day 29; Wincing and attempt to withdraw (n=56, 52)
|
1 participants
|
0 participants
|
|
Number of Participants With Categorical Tenderness
Day 57; No tenderness(n=47, 41)
|
33 participants
|
30 participants
|
|
Number of Participants With Categorical Tenderness
Day 57; Complaint of tenderness (n=47, 41)
|
14 participants
|
10 participants
|
|
Number of Participants With Categorical Tenderness
Day 57; CTW (n=47, 41)
|
0 participants
|
1 participants
|
|
Number of Participants With Categorical Tenderness
Day 57; wincing and attempt to withdraw(n=47, 41)
|
0 participants
|
0 participants
|
|
Number of Participants With Categorical Tenderness
Day 85; No tenderness(n=55, 56)
|
39 participants
|
44 participants
|
|
Number of Participants With Categorical Tenderness
Day 85; CTW (n=55, 56)
|
0 participants
|
2 participants
|
|
Number of Participants With Categorical Tenderness
Day 85; Wincing and attempt to withdraw(n=55, 56)
|
1 participants
|
0 participants
|
Adverse Events
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Tramadol Hydrochloride Plus Acetaminophen
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=73 participants at risk
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=67 participants at risk
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Vascular disorders
Thromboangiitis obliterans
|
1.4%
1/73
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
0.00%
0/67
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
Other adverse events
| Measure |
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
n=73 participants at risk
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
|
Tramadol Hydrochloride Plus Acetaminophen
n=67 participants at risk
Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.6%
7/73
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
6.0%
4/67
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
|
Gastrointestinal disorders
Constipation
|
8.2%
6/73
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
7.5%
5/67
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.1%
3/73
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
6.0%
4/67
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
|
Gastrointestinal disorders
Dizziness
|
8.2%
6/73
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
7.5%
5/67
Safety population included all participants who received at least 1 dose study drug and had safety data.
|
Additional Information
Clinical Research Director
Janssen Korea / 25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702 Korea
Phone: 82-2-2094-4518
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
- Publication restrictions are in place
Restriction type: OTHER