Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acetylsalicylic Acid · 8 trials · 8 indications
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Sequence 1: starting with BAYE4465 500 mg | EXPERIMENTAL | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 2: starting with BAYE4465 1000 mg | EXPERIMENTAL | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 3: starting with Nurofen | EXPERIMENTAL | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| Sequence 4: starting with Dolormin Extra | EXPERIMENTAL | Participants will participant four treatment periods with four different treatments. Treatment assignment adhere to Williams design |
| IR ASA co-administered with naproxen sodium | EXPERIMENTAL | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| IR ASA 30 min after naproxen sodium | EXPERIMENTAL | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| IR ASA 8 hours after naproxen sodium | EXPERIMENTAL | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| IR ASA only | ACTIVE_COMPARATOR | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| IR ASA 30 min before naproxen sodium | EXPERIMENTAL | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| IR ASA 30 min after first dose of naproxen sodium bid | EXPERIMENTAL | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. |
| Acetylsalicylic acid [1000mg] | EXPERIMENTAL | - |
| Acetylsalicylic acid [500mg] | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acetylsalicylic Acid (Aspirin, BAYE4465) | DRUG | 2 Sachets of 500 mg Aspirin Complex. |
| Pseudoephedrine | DRUG | 2 Sachets of 30 mg Pseudoephedrine |
| Placebo | DRUG | Matching Placebo |
| Ibuprofen | DRUG | Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen. |
| Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain | DRUG | Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge) |
| Lidocain | DRUG | Single oral application of Lidocain (as lozenge) |
| 500 mg acetylsalicylic acid (Aspirin, BAYE4465) | DRUG | Single intake of 1 tablet, 500mg |
| 1000 mg acetylsalicylic acid (Aspirin, BAYE4465) | DRUG | Single intake of 1 tablet, 1000mg |
| 400 mg ibuprofen(Nurofen) | DRUG | Single intake of 1 tablet, 400mg |
| 400 mg ibuprofen (Dolormin Extra) | DRUG | Single intake of 1 tablet, 400mg |
| Naproxen Sodium (Aleve, BAY117031) | DRUG | Naproxen sodium 220 mg qd or bid |
| Acetylsalicylic acid (Aspirin, BAY1019036) | DRUG | One Fast Release Tablet containing 1000 mg acetylsalicylic acid |
| Acetylsalicylic Acid (Aspirin BAY1019036) | DRUG | One tablet of new formula Aspirin under fasting conditions |
| Alka Seltzer Extra Strength | DRUG | One effervescent tablet under fasting conditions |
| Aspirin Migraine | DRUG | One effervescent tablet under fasting conditions |
| Aspirin Aspro | DRUG | One effervescent tablet under fasting conditions |
Inclusion Criteria: * Patient in general good health with suspected viral upper respiratory tract infection (common cold) Exclusion Criteria: * \< 18 years old
Acetylsalicylic Acid, also known as aspirin, is a small molecule being developed by Bayer AG for use in hematology, common cold, low back pain, pain, pharmacokinetics, and moderate pain. It is currently in Phase 3 clinical development for these indications.
Bayer AG (ticker: BAYRY) is developing Acetylsalicylic Acid. The drug is a small molecule being studied for pain-related conditions and other indications, and it is currently in Phase 3 clinical trials.
Acetylsalicylic Acid is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The development program includes completed Phase 1 trials, with the drug being evaluated for pain and other conditions.
Acetylsalicylic Acid has completed several clinical trials, including NCT01072604, NCT01081353, NCT02229461, and NCT03056703. These Phase 1 studies evaluated pharmacokinetics, hematology, and pain, with a total enrollment of 211 participants across the trials.
Yes, Acetylsalicylic Acid is the same as aspirin. It is being developed by Bayer AG for pain-related conditions and other indications, and is currently in Phase 3 clinical development.