Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paracetamol · 4 trials · 4 indications
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).
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
Maximum plasma concentration of paracetamol.
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
| 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. |
| Experimental Paracetamol Tablet | EXPERIMENTAL | Experimental paracetamol tablet (500 milligrams \[mg\]) administered with 240 milliliters (mL) of water. |
| Standard Paracetamol Tablet (500 mg) | ACTIVE_COMPARATOR | Standard paracetamol tablet (500 mg) administered with 240 mL of water. |
| Standard paracetamol | ACTIVE_COMPARATOR | Marketed formulation |
| Formulation 1 | EXPERIMENTAL | Paracetamol formulation 1 |
| Formulation 2 | EXPERIMENTAL | Paracetamol formulation 2 |
| Formulation 3 | EXPERIMENTAL | Paracetamol formulation 3 |
| Formulation 4 | EXPERIMENTAL | Paracetamol formulation 4 |
| 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 |
| Paracetamol | DRUG | 500 mg immediate release paracetamol formulations |
| Paracetamol formulation 1 | DRUG | Paracetamol |
| Paracetamol Formulation 2 | DRUG | Paracetamol |
| Paracetamol formulation 3 | DRUG | Paracetamol |
| Paracetamol formulation 4 | DRUG | paracetamol |
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...
Paracetamol is used for pain, common cold, fever, and analgesia. It has been studied in conditions including pain, headache disorders, and osteoarthritis. The drug is also evaluated in healthy volunteers for pharmacokinetic studies.
Paracetamol is developed by GSK plc, which trades under the ticker GSK. The company has conducted clinical trials for this small molecule drug across multiple indications.
Paracetamol is in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 3 trial. The drug remains investigational and is not approved for any indication.
Paracetamol has completed clinical trials including NCT01551797, a pharmacokinetic study comparing sustained release and standard formulations, and NCT01568749, investigating extended release formulations. NCT01767428 compared two formulations, and NCT02311881 was a 12-week efficacy study in osteoarthritis patients.
Paracetamol is the generic name for the drug also known as acetaminophen in some regions. It is a small molecule used for pain and fever relief, developed by GSK plc.