Trial · NCT02311881
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
NCT02311881, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis. Trials, record NCT02311881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02311881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
- NCT number
- NCT02311881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 960 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pain
- Interventions
- Paracetamol 1000 mg SR tablets, Paracetamol 665 mg SR tablets, Placebo
- First posted
- 2014-12-09
- Last updated
- 2017-04-07
- Results first posted
- 2017-04-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | Baseline up to week 12 | 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). |
| Secondary | Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | Baseline up to Week 12 | 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). |
| Secondary | Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | Baseline up to week 12 | 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). |
| Secondary | Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment | Baseline up to week 12 | 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. |
| Secondary | Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA) | Baseline, Week 4, Week 8, Week 12 | 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. |
| Secondary | Number of Participants Classified as Responder | Baseline, Week 12 | 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. |
| Secondary | Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12 | Baseline, 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. |
| Secondary | Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks | every 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. |
| Secondary | Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI) | Baseline, Week 4, Week 8, Week 12 | 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). |
| Secondary | Patient Global Assessment of Response to Therapy (PGART) | Week 4, Week 8, Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | Baseline up to week 12 | Modified intent to treat (mITT) population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified. | millimeter(mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | Baseline up to Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified. | mm | MEAN |
| SECONDARY | Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | Baseline up to week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified. | mm | MEAN |
| SECONDARY | Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment | Baseline up to week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified. | mm | MEAN |
| SECONDARY | Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA) | Baseline, Week 4, Week 8, Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified. | mm | MEAN |
| SECONDARY | Number of Participants Classified as Responder | Baseline, Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12 | Baseline, Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified. | score on a scale | MEAN |
| SECONDARY | Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks | every day up to 12 weeks | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified. | number of rescue medication pills/day | MEAN |
| SECONDARY | Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI) | Baseline, Week 4, Week 8, Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified. | mm | MEAN |
| SECONDARY | Patient Global Assessment of Response to Therapy (PGART) | Week 4, Week 8, Week 12 | Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment \& had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group159
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | Paracetamol 2000 mg Twice Daily (BID) | -28.25 | Standard Error 1.697 | millimeter(mm) | |
| Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | Paracetamol 1330 mg Thrice Daily (TID) | -25.89 | Standard Error 1.714 | millimeter(mm) | |
| Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment | Placebo | -25.74 | Standard Error 1.713 | millimeter(mm) | |
| Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | Paracetamol 2000 mg Twice Daily (BID) | -28.24 | Standard Deviation 21.341 | mm | |
| Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | Paracetamol 1330 mg Thrice Daily (TID) | -26.23 | Standard Deviation 22.028 | mm | |
| Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment | Placebo | -26.68 | Standard Deviation 20.137 | mm | |
| Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | Paracetamol 2000 mg Twice Daily (BID) | -27.68 | Standard Deviation 21.579 | mm | |
| Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | Paracetamol 1330 mg Thrice Daily (TID) | -25.61 | Standard Deviation 22.238 | mm | |
| Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment | Placebo | -26.16 | Standard Deviation 21.554 | mm | |
| Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment | Paracetamol 2000 mg Twice Daily (BID) | -0.28 | Standard Deviation 0.209 | mm |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paracetamol 2000 mg Twice Daily (BID) | 235 | |
| Overall Study | STARTED | Paracetamol 1330 mg Thrice Daily (TID) | 236 | |
| Overall Study | STARTED | Placebo | 237 | |
| Overall Study | Safety Population | Paracetamol 2000 mg Twice Daily (BID) | 234 | |
| Overall Study | Safety Population | Paracetamol 1330 mg Thrice Daily (TID) | 236 | |
| Overall Study | Safety Population | Placebo | 237 | |
| Overall Study | COMPLETED | Paracetamol 2000 mg Twice Daily (BID) | 200 | |
| Overall Study | COMPLETED | Paracetamol 1330 mg Thrice Daily (TID) | 193 | |
| Overall Study | COMPLETED | Placebo | 196 | |
| Overall Study | NOT COMPLETED | Paracetamol 2000 mg Twice Daily (BID) | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events381
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NAUSEA | Gastrointestinal disorders | Paracetamol 2000 mg Twice Daily (BID) | 8 | 234 | |
| other | NAUSEA | Gastrointestinal disorders | Paracetamol 1330 mg Thrice Daily (TID) | 5 | 236 | |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 4 | 237 | |
| other | DIARRHOEA | Gastrointestinal disorders | Paracetamol 2000 mg Twice Daily (BID) | 6 | 234 | |
| other | DIARRHOEA | Gastrointestinal disorders | Paracetamol 1330 mg Thrice Daily (TID) | 7 | 236 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 2 | 237 | |
| other | FLATULENCE | Gastrointestinal disorders | Paracetamol 2000 mg Twice Daily (BID) | 4 | 234 | |
| other | FLATULENCE | Gastrointestinal disorders | Paracetamol 1330 mg Thrice Daily (TID) | 0 | 236 | |
| other | FLATULENCE | Gastrointestinal disorders | Placebo | 1 | 237 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Paracetamol 2000 mg Twice Daily (BID) | 3 | 234 |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paracetamol 2000 mg Twice Daily (BID) | ||
| Total, all-cause mortality | Paracetamol 1330 mg Thrice Daily (TID) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Paracetamol 2000 mg Twice Daily (BID) | 67 | 234 |
| Total, other adverse events | Paracetamol 1330 mg Thrice Daily (TID) | 69 | 236 |
| Total, other adverse events | Placebo | 51 | 237 |
| Total, serious adverse events | Paracetamol 2000 mg Twice Daily (BID) | 4 | 234 |
| Total, serious adverse events | Paracetamol 1330 mg Thrice Daily (TID) | 5 | 236 |
| Total, serious adverse events | Placebo | 0 | 237 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02311881
GET https://conductscience.org/api/trials/v1/NCT02311881/results?page=2