A Phase 4 interventional study of Meloxicam and Aceclofenac in Osteoarthritis, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-22.
Sponsored by Janssen Korea, Ltd., Korea · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.
This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), comparative study to compare the efficacy of tramadol hydrochloride plus acetaminophen maintenance with that of NSAIDs maintenance in participants whose pain was relieved after the add-on treatment of tramadol 37.5 milligram (mg) plus acetaminophen 325 mg to NSAIDs. All participants will receive tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam [7.5 mg or 15 mg once daily] or aceclofenac [100 mg twice daily]) from Day 1 to Day 28, and participants will be randomly assigned into 2 treatment groups at Day 29 if the numerical rating scale score less than or equal 4. Tramadol plus acetaminophen group will receive 1 or 2 tablets containing tramadol 37.5 mg plus acetaminophen 325 mg 4 times daily (maximum daily dose will be 8 tablets) from Day 29 to Day 85 and NSAIDs group will receive either meloxicam 7.5 mg or 15 mg per day or aceclofenac 100 mg twice a day from Day 29 to Day 85. The efficacy will be evaluated on Day 1, Day 29, Day 57 and Day 85. The primary efficacy end point will be assessed through change in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score from Day 29 to Day 85. Participant's safety will be monitored throughout the study.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 143 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 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 will have the numeric rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of NSAIDs to receive either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Drug: Meloxicam · Drug: Aceclofenac · Drug: Tramadol Hydrochloride Plus Acetaminophen
Participants will receive 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 will have the numerical rating scale score 4 or less on Day 29 will be 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 will be 8 tablets).
Drug: Meloxicam · Drug: Aceclofenac · Drug: Tramadol Hydrochloride Plus Acetaminophen
Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and 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 will be 8 tablets).
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
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.
Time frame: Day 29 and Day 85
Change From Day 29 in Pain Intensity Score at Day 85
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.
Time frame: Day 29 and Day 85
Number of Participants With Pain Relief
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.
Time frame: Day 29, Day 57 and Day 85
Number of Participants With Overall Assessment on Study Drug by Participants
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.
Time frame: Day 85
Number of Participants With Overall Assessment on Study Drug by Investigator
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.
Time frame: Day 85
Number of Participants With Categorical Swelling
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).
Time frame: Day 29, Day 57 and Day 85
Number of Participants With Categorical Tenderness
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.
Time frame: Day 29, Day 57 and Day 85
| Milestone | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Started | 73 | 67 |
| Completed | 29 | 19 |
| Not completed | 44 | 48 |
| Withdrew: Other | 8 | 6 |
| Withdrew: Protocol violation | 18 | 22 |
| Withdrew: Withdrawal by subject | 3 | 8 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Adverse event | 11 | 9 |
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.
| units on a scale | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Day 29 | 33.54 ± 15.01 | 39.44 ± 14.17 |
| Change at Day 85 | -1.88 ± 11.07 | -0.07 ± 13.46 |
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.
| units on a scale | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Day 29 | 3.82 ± 1.22 | 3.81 ± 1.03 |
| Change at Day 85 | 0.14 ± 1.76 | 0.83 ± 2.02 |
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.
| participants | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Day 29; Pain relieved (n=56, 52) | 49 | 42 |
| Day 57; Pain relieved (n=47, 41) | 32 | 28 |
| Day 85; Pain relieved (n=55, 56) | 42 | 35 |
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.
| participants | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Very bad | 1 | 1 |
| Bad | 2 | 11 |
| Moderate | 21 | 22 |
| Good | 29 | 21 |
| Very good | 4 | 2 |
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.
| participants | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Very bad | 1 | 0 |
| Bad | 1 | 6 |
| Moderate | 21 | 25 |
| Good | 31 | 24 |
| Very good | 3 | 2 |
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).
| participants | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Day 29; No swelling (n=56, 52) | 52 | 45 |
| Day 29; PCFF (n=56, 52) | 4 | 7 |
| Day 57; No swelling (n=47, 41) | 43 | 38 |
| Day 57; PCFF (n=47, 41) | 4 | 3 |
| Day 85; No swelling (n=55, 56) | 53 | 46 |
| Day 85; PCFF (n=55, 56) | 1 | 9 |
| Day 85; Patellar ballotment (n=55, 56) | 1 | 1 |
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.
| participants | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Day 29; No tenderness(n=56, 52) | 33 | 37 |
| Day 29; Complaint of tenderness (n=56, 52) | 22 | 14 |
| Day 29; CTW (n=56, 52) | 0 | 1 |
| Day 29; Wincing and attempt to withdraw (n=56, 52) | 1 | 0 |
| Day 57; No tenderness(n=47, 41) | 33 | 30 |
| Day 57; Complaint of tenderness (n=47, 41) | 14 | 10 |
| Day 57; CTW (n=47, 41) | 0 | 1 |
| Day 57; wincing and attempt to withdraw(n=47, 41) | 0 | 0 |
| Day 85; No tenderness(n=55, 56) | 39 | 44 |
| Day 85; Complaint of tenderness (n=55, 56) | 15 | 10 |
| Day 85; CTW (n=55, 56) | 0 | 2 |
| Day 85; Wincing and attempt to withdraw(n=55, 56) | 1 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | — | 1/73 (1.4%) | 17/73 (23.3%) |
| Tramadol Hydrochloride Plus Acetaminophen | — | 0/67 (0%) | 12/67 (17.9%) |
| Event | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| Thromboangiitis obliteransVascular disorders | 1/73 | 0/67 |
| Event | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen |
|---|---|---|
| NauseaGastrointestinal disorders | 7/73 | 4/67 |
| ConstipationGastrointestinal disorders | 6/73 | 5/67 |
| DizzinessGastrointestinal disorders | 6/73 | 5/67 |
| DyspepsiaGastrointestinal disorders | 3/73 | 4/67 |
| Age Continuous(years) | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen | Total |
|---|---|---|---|
| Mean | 60.0 ± 8.0 | 62.3 ± 7.6 | 61.1 ± 7.9 |
| Sex: Female, Male(Participants) | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen | Total |
|---|---|---|---|
| Female | 62 | 56 | 118 |
| Male | 11 | 11 | 22 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Korea, Ltd., Korea