Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02311881 | A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis | PHASE3 | COMPLETED | 960 | — | — | Jan 1, 2015 | Feb 1, 2016 | Apr 7, 2017 | 56 | United States |
| NCT01551797 | A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations. | PHASE1 | COMPLETED | 14 | — | — | May 1, 2010 | Oct 1, 2010 | Dec 10, 2012 | 1 | United States |
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 period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (μg)/milliliter (mL).
| Arm | Type | Description |
|---|---|---|
| Paracetamol 2000 mg twice daily (BID) | EXPERIMENTAL | 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. |
| Paracetamol 1330 mg thrice daily (TID) | ACTIVE_COMPARATOR | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Test Sustained Release (SR) Paracetamol (2000 mg) | EXPERIMENTAL | A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water. |
| Test SR Paracetamol (1500 mg) | EXPERIMENTAL | A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water. |
| Reference Paracetamol (2000 mg) | ACTIVE_COMPARATOR | Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water. |
| Name | Type | Description |
|---|---|---|
| Paracetamol 1000 mg SR tablets | DRUG | 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. |
| Paracetamol 665 mg SR tablets | DRUG | 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. |
| Placebo | DRUG | 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. |
| Paracetamol 500 mg | DRUG | Standard Paracetamol formulation |
| Paracetamol 1000 mg | DRUG | Paracetamol Sustained Release formulation |
| Paracetamol 750 mg | DRUG | Paracetamol Sustained Release formulation |
Inclusion Criteria: * Male or female participants between 40 and 80 years of age * Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or hip with respect to the following: * Pain in one knee/hip over 3 months immediately before screening visit * Use of non steroi...