A Phase 3 interventional study of Paracetamol 1000 mg SR tablets and Paracetamol 665 mg SR tablets in Pain, sponsored by GlaxoSmithKline. Completed at 56 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 960 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or hip with respect to the following:
Exclusion Criteria:
Participants will be instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Drug: Paracetamol 1000 mg SR tablets
Participants will be instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Drug: Paracetamol 665 mg SR tablets
Participants will be instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Drug: Placebo
Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.
Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).
Time frame: Baseline up to week 12
Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).
Time frame: Baseline up to Week 12
Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline).
Time frame: Baseline up to week 12
Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement.
Time frame: Baseline up to week 12
Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)
Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to "With respect to your arthritis condition, how would you describe yourself now?" GPAOA was calculated periodically during the 12 week treatment period.
Time frame: Baseline, Week 4, Week 8, Week 12
Number of Participants Classified as Responder
A participant was considered a "responder" if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high' or 'moderate' improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA.
Time frame: Baseline, Week 12
Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12
Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 12
Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks
Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated.
Time frame: every day up to 12 weeks
Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)
Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep).
Time frame: Baseline, Week 4, Week 8, Week 12
Patient Global Assessment of Response to Therapy (PGART)
The PGART is a global assessment of the participant's response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period.
Time frame: Week 4, Week 8, Week 12
This study was conducted in 57 centers in United States.
| Milestone | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Started | 235 | 236 | 237 |
| Safety population | 234 | 236 | 237 |
| Completed | 200 | 193 | 196 |
| Not completed | 35 | 43 | 41 |
| Withdrew: Did not meet the study criteria | 2 | 2 | 0 |
| Withdrew: Adverse event | 7 | 15 | 8 |
| Withdrew: Lost to follow-up | 3 | 3 | 2 |
| Withdrew: Protocol violation | 1 | 2 | 3 |
| Withdrew: Withdrawal of consent | 14 | 16 | 17 |
| Withdrew: Other | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 2 | 0 |
| Withdrew: Subject has border line pregnancy test | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 4 |
| Withdrew: Sponsor decision | 1 | 1 | 1 |
| Withdrew: Protocol deviation | 1 | 0 | 0 |
| Withdrew: Non-compliance | 1 | 0 | 2 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Medical monitor discretion | 0 | 0 | 1 |
| Withdrew: Participant taking another medication | 0 | 0 | 1 |
| Withdrew: Serious adverse event | 0 | 1 | 0 |
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).
| millimeter(mm) | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | -28.25 ± 1.697 | -25.89 ± 1.714 | -25.74 ± 1.713 |
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).
| mm | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | -28.24 ± 21.341 | -26.23 ± 22.028 | -26.68 ± 20.137 |
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline).
| mm | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | -27.68 ± 21.579 | -25.61 ± 22.238 | -26.16 ± 21.554 |
The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement.
| mm | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment | -0.28 ± 0.209 | -0.26 ± 0.217 | -0.27 ± 0.200 |
Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to "With respect to your arthritis condition, how would you describe yourself now?" GPAOA was calculated periodically during the 12 week treatment period.
| mm | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| At Baseline | 68.23 ± 16.965 | 69.20 ± 16.607 | 69.79 ± 16.734 |
| At Week 4 | 39.34 ± 20.605 | 41.46 ± 22.330 | 42.93 ± 21.856 |
| Change from baseline at Week 4 | -29.02 ± 22.343 | -27.78 ± 26.398 | -26.83 ± 24.229 |
| At Week 8 | 36.08 ± 22.662 | 37.62 ± 23.523 | 39.09 ± 21.858 |
| Change from baseline at Week 8 | -32.51 ± 24.429 | -31.15 ± 28.064 | -31.00 ± 23.649 |
| At Week 12 | 32.41 ± 23.737 | 36.04 ± 23.848 | 35.44 ± 20.546 |
| Change from baseline at Week 12 | -36.15 ± 26.192 | -33.04 ± 29.547 | -34.31 ± 25.521 |
A participant was considered a "responder" if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high' or 'moderate' improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA.
| participants | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Number of Participants Classified as Responder | 157 | 148 | 159 |
Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement.
| score on a scale | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Pain at Baseline (n= 224, 225, 227) | 6.39 ± 1.902 | 6.27 ± 1.942 | 6.63 ± 1.774 |
| Pain at Week 12(n= 176, 175, 177) | 3.80 ± 2.454 | 3.80 ± 2.197 | 3.82 ± 2.056 |
| Pain, Change at Week 12 (n= 176, 175, 177) | -2.54 ± 2.301 | -2.49 ± 2.457 | -2.91 ± 2.442 |
| Stiffness at Baseline (n= 224, 225, 227) | 6.20 ± 2.015 | 6.13 ± 1.908 | 6.38 ± 1.842 |
| Stiffness at Week 12(n= 176, 175, 177) | 3.56 ± 2.383 | 3.63 ± 2.246 | 3.72 ± 2.145 |
| Stiffness, Change at Week 12(n= 176, 175, 177 | -2.56 ± 2.227 | -2.44 ± 2.361 | -2.76 ± 2.500 |
| Composite at Baseline (n= 224, 225, 227) | 6.30 ± 1.883 | 6.20 ± 1.817 | 6.51 ± 1.729 |
| Composite at Week 12(n= 176, 175, 177) | 3.68 ± 2.361 | 3.71 ± 2.150 | 3.77 ± 2.043 |
| Composite, Change at Week 12(n= 176, 175, 177 | -2.55 ± 2.209 | -2.46 ± 2.347 | -2.83 ± 2.410 |
Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated.
| number of rescue medication pills/day | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks | 0.356 ± 1.7910 | 0.200 ± 0.8052 | 0.337 ± 1.1254 |
Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep).
| mm | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| At Baseline, CPSI-1 | 60.40 ± 26.089 | 57.77 ± 27.705 | 61.30 ± 25.500 |
| At Baseline, CPSI-3 | 59.21 ± 26.980 | 57.19 ± 28.829 | 60.50 ± 25.532 |
| At Baseline, CPSI-4 | 58.49 ± 27.759 | 56.94 ± 28.834 | 61.30 ± 25.773 |
| At Baseline, Sleep Problems Index | 59.36 ± 25.886 | 57.26 ± 27.384 | 61.04 ± 24.156 |
| At Week 4, CPSI-1 | 32.32 ± 25.396 | 29.23 ± 26.718 | 34.01 ± 24.701 |
| At Week 4, Change in CPSI-1 | -27.87 ± 24.563 | -27.61 ± 28.248 | -27.44 ± 26.746 |
| At Week 4, CPSI-3 | 32.54 ± 26.437 | 28.94 ± 27.232 | 32.75 ± 24.833 |
| At Week 4, Change in CPSI-3 | -26.63 ± 25.621 | -27.51 ± 28.497 | -27.69 ± 26.257 |
| At Week 4, CPSI-4 | 31.70 ± 25.667 | 28.85 ± 26.365 | 33.80 ± 25.749 |
| At Week 4, Change in CPSI-4 | -26.55 ± 25.230 | -27.52 ± 28.135 | -27.47 ± 27.265 |
| At Week 4, Sleep Problems Index | 32.16 ± 24.845 | 28.96 ± 26.102 | 33.52 ± 24.004 |
| At Week 4, Change in Sleep Problems Index | -27.04 ± 23.458 | -27.59 ± 26.860 | -27.53 ± 24.930 |
| At Week 8, CPSI-1 | 30.53 ± 26.672 | 29.22 ± 26.468 | 30.84 ± 24.277 |
| At Week 8, Change in CPSI-1 | -29.98 ± 26.601 | -27.45 ± 28.842 | -31.34 ± 25.290 |
| At Week 8, CPSI-3 | 30.25 ± 27.329 | 29.45 ± 27.286 | 29.71 ± 24.478 |
| At Week 8, Change at CPSI-3 | -29.16 ± 27.321 | -26.91 ± 28.210 | -30.83 ± 25.892 |
| At Week 8, CPSI-4 | 30.33 ± 26.856 | 29.12 ± 27.444 | 31.02 ± 24.625 |
| At Week 8, Change at CPSI-4 | -28.19 ± 27.359 | -26.78 ± 29.961 | -30.11 ± 25.874 |
| At Week 8, Sleep Problems Index | 30.33 ± 26.206 | 29.20 ± 26.533 | 30.50 ± 23.868 |
| At Week 8, Change in Sleep Problems Index | -29.15 ± 25.838 | -27.11 ± 27.784 | -30.78 ± 24.315 |
| At Week 12, CPSI-1 | 26.73 ± 25.302 | 26.90 ± 25.288 | 27.64 ± 21.977 |
| At Week 12, Change in CPSI-1 | -33.12 ± 27.859 | -30.17 ± 30.532 | -34.43 ± 25.975 |
| At Week 12, CPSI-3 | 26.95 ± 25.124 | 26.63 ± 25.684 | 27.42 ± 21.827 |
| At Week 12, Change in CPSI-3 | -32.23 ± 29.228 | -29.99 ± 29.859 | -33.01 ± 27.116 |
| At Week 12, CPSI-4 | 27.26 ± 25.887 | 26.85 ± 25.812 | 27.79 ± 22.581 |
| At Week 12, Change in CPSI-4 | -30.90 ± 29.052 | -29.73 ± 30.967 | -32.97 ± 27.357 |
| At Week 12, Sleep Problems Index | 26.96 ± 24.709 | 26.72 ± 25.135 | 27.61 ± 21.593 |
| At Week 12, Change in Sleep Problems Index | -32.11 ± 27.489 | -30.03 ± 29.275 | -33.48 ± 25.485 |
The PGART is a global assessment of the participant's response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period.
| score on a scale | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| At Week 4 (n=197, 188, 202) | 2.50 ± 0.867 | 2.43 ± 0.871 | 2.25 ± 0.900 |
| At Week 8(n=196, 184, 192) | 2.58 ± 0.852 | 2.40 ± 0.998 | 2.44 ± 0.958 |
| At Week 12(n=189, 182, 181) | 2.62 ± 0.870 | 2.46 ± 1.022 | 2.43 ± 1.045 |
Collected over throughout the study completion (up to 408 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paracetamol 2000 mg Twice Daily (BID) | — | 4/234 (1.7%) | 67/234 (28.6%) |
| Paracetamol 1330 mg Thrice Daily (TID) | — | 5/236 (2.1%) | 69/236 (29.2%) |
| Placebo | — | 0/237 (0%) | 51/237 (21.5%) |
| Event | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| CHEST PAINGeneral disorders | 1/234 | 0/236 | 0/237 |
| ABDOMINAL PAINGastrointestinal disorders | 1/234 | 0/236 | 0/237 |
| DEHYDRATIONMetabolism and nutrition disorders | 1/234 | 0/236 | 0/237 |
| COLON CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/234 | 0/236 | 0/237 |
| OESOPHAGEAL CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/234 | 1/236 | 0/237 |
| CHOLELITHIASISHepatobiliary disorders | 0/234 | 1/236 | 0/237 |
| GUN SHOT WOUNDInjury, poisoning and procedural complications | 0/234 | 1/236 | 0/237 |
| MULTIPLE INJURIESInjury, poisoning and procedural complications | 0/234 | 1/236 | 0/237 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 0/234 | 1/236 | 0/237 |
| Event | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo |
|---|---|---|---|
| NAUSEAGastrointestinal disorders | 8/234 | 5/236 | 4/237 |
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 7/234 | 4/236 | 0/237 |
| DIARRHOEAGastrointestinal disorders | 6/234 | 7/236 | 2/237 |
| GASTROENTERITISInfections and infestations | 6/234 | 1/236 | 1/237 |
| HYPERTENSIONVascular disorders | 6/234 | 2/236 | 1/237 |
| CONSTIPATIONGastrointestinal disorders | 1/234 | 6/236 | 2/237 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 5/234 | 3/236 | 2/237 |
| HEADACHENervous system disorders | 5/234 | 5/236 | 5/237 |
| FLATULENCEGastrointestinal disorders | 4/234 | 0/236 | 1/237 |
| ABDOMINAL DISCOMFORTGastrointestinal disorders | 2/234 | 2/236 | 4/237 |
Baseline data are displayed for the safety population; i.e. for the population of all treated participants. One participant was randomized but did not receive any treatment.
| Age, Continuous(Years) | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo | Total |
|---|---|---|---|---|
| Mean | 60.27 ± 8.544 | 60.47 ± 8.410 | 61.46 ± 8.187 | 60.73 ± 8.385 |
| Sex: Female, Male(Participants) | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo | Total |
|---|---|---|---|---|
| Female | 146 | 147 | 150 | 443 |
| Male | 88 | 89 | 87 | 264 |
| Race/Ethnicity, Customized(number of participants) | Paracetamol 2000 mg Twice Daily (BID) | Paracetamol 1330 mg Thrice Daily (TID) | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 77 | 81 | 95 | 253 |
| Not Hispanic or Latino | 157 | 155 | 142 | 454 |
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline