Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
paracetamol+ caffeine · 1 trial · 1 indication
The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.
| Arm | Type | Description |
|---|---|---|
| highest dose Paracetamol + caffeine | ACTIVE_COMPARATOR | highest dose of Paracetamol and caffeine |
| low-dose Paracetamol + caffeine | ACTIVE_COMPARATOR | lowest dose of Paracetamol and caffeine |
| high dose paracetamol | ACTIVE_COMPARATOR | highest dose paracetamol |
| low dose paracetamol | ACTIVE_COMPARATOR | lowest dose paracetamol |
| Name | Type | Description |
|---|---|---|
| paracetamol + caffeine | DRUG | paracetamol with caffeine |
| paracetamol | DRUG | paracetamol |
* Participants with symptoms of cold \< 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold. * No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in...
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.