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A recently developed fast-release aspirin tablet formulation has been evaluated in two different pain models. The dental impaction pain model and the sore throat pain model are widely used for assessing analgesia, including acute mild-to-moderate pain. Both studies were double-blind, randomized, parallel group and compared a single dose of 1000 mg aspirin with 1000 mg paracetamol and with placebo and investigated the onset and overall time course of pain relief. Speed of onset was measured by the double-stopwatch method for time to meaningful pain relief and time to first perceptible pain relief. Pain intensity and pain relief were rated subjectively over a 6-h (dental pain) and 2-h (sore throat pain) time period. In both models fast-release aspirin and commercial paracetamol were statistically significantly different from placebo for onset of action, summed pain intensity differences and total pain relief. Meaningful pain relief was achieved within a median of 42.3 and 42.9 min for aspirin and paracetamol, respectively, in the dental pain model. The corresponding numbers in sore throat pain were 48.0 and 40.4 min. All treatments in both studies were safe and well tolerated. No serious adverse events were reported and no subject was discontinued due to an adverse event. Overall the two studies clearly demonstrated efficacy over placebo in the two pain models and a comparable efficacy and safety profile between aspirin and an equivalent dose of paracetamol under the conditions of acute dental pain and acute sore throat pain. Trial registration These trials were registered with ClinicalTrials.gov, registration number: NCT01420094, registration date: July 27, 2011 and registration number: NCT01453400, registration date: October 13, 2011.

A new formulation of a micronized acetylsalicylic acid swallowable tablet with an effervescent component (FR-aspirin) was evaluated in two independent studies using the dental impaction pain model. These clinical studies were performed to confirm the results of preclinical dissolution studies and human pharmacokinetic studies, which indicated an improved onset of analgesia without compromising duration of effect or safety. Study 1 evaluated a 650-mg dose of aspirin and Study 2 evaluated a 1,000-mg dose of aspirin. Both studies were double-blinded, parallel group and compared to regular aspirin (R-aspirin) and placebo. Speed of onset was measured by the double stopwatch method for time to both first perceptible relief and meaningful relief. In both studies, the FR-aspirin was significantly faster (p<0.038-0.001) than both R-aspirin and placebo for both onset measures. There were no significant differences between FR-aspirin and R-aspirin for peak or total effects and both treatments were significantly better than placebo. For first perceptible relief, FR-aspirin onset was 19.8 and 16.3 min for 650 mg and 1,000 mg, respectively, compared to 23.7 and 20.0 for R-aspirin. For meaningful relief, FR-aspirin onset was 48.9 and 49.4 min for 650 mg and 1,000 mg, respectively, compared to 119.2 and 99.2 for R-aspirin. These efficacy studies clearly demonstrate that the onset of analgesic efficacy is dramatically improved by adding an effervescent component and micronized active ingredient to the swallowable tablet aspirin formulation. The enhanced onset did not adversely impact either the peak effect or duration of effect or tolerability compared to regular aspirin.

Background: Patients taking aspirin for cardioprotection may occasionally take over-the-counter (OTC) ibuprofen for pain relief, which might interfere with the antiplatelet effects of aspirin., Objective: The present study was undertaken to determine whether ibuprofen, taken according to OTC label directions, would affect inhibition of thromboxane B2 (TXB2), a surrogate for platelet inhibition., Methods: This was a prospective, multiple-dose,single-center, double-blind, randomized, parallel, placebo-controlled study. Eligible subjects received chewable, immediate-release aspirin 81 mg QD for 8 days, and were then randomized to receive either ibuprofen 400 mg TID or placebo TID, in addition to aspirin, for 10 days., Results: Fifty-one subjects were randomized; 47(24 placebo, 23 ibuprofen) completed the study. No subjects withdrew prematurely. Subjects were predominantly white (49%) or black (38%), and 53% were male. The mean (SD) age was 38.4 (9.8) years and mean (SD) body weight was 173.2 (26.7) pounds. On days 1, 3, 7, and 10 of the study period, mean TXB2 inhibitions were 99.24%, 98.88%, 97.75%, and 98.17% for ibuprofen and 98.82%, 98.93%, 98.75%, and 98.83% for placebo. Although a statistically significant reduction of TXBZ inhibition was seen in the ibuprofen group at days 7 and 10 (P = 0.003 and P = 0.023, respectively), TXBZ inhibition was >90% on all days tested in all subjects. Aspirin, ibuprofen, and placebo were all well tolerated. There were 3 adverse events (1 mild and 2 moderate) during the aspirin run-in period and 8 (2 mild and 6 moderate) during the randomized study period., Conclusions: No clinically meaningful loss of cardioprotection was found, as reflected by TXB2 inhibition in healthy volunteers who received OTC doses of ibuprofen. When using this regimen of OTC ibuprofen with immediate-release, low-dose aspirin, concerns about the loss of cardioprotective antiplatelet effects of aspirin are not supported by this study.

This single-dose, double-blind, randomized, placebo-controlled study evaluated the analgesic efficacy of both 25 and 50 mg of flurbiprofen (Ansaid, Upjohn) compared with 650 mg of aspirin and placebo in 164 patients who had undergone dental impaction surgery. Using the highly sensitive dental pain model, flurbiprofen appears to be an effective, peripherally acting analgesic with a rapid onset of activity. In the current study, it was superior to aspirin in terms of peak effect and duration of action. Although flurbiprofen is much more potent than ibuprofen, its side-effect profile did not differ markedly from that of ibuprofen in this single-dose study.

To evaluate the analgesic efficacy of orally administered 50 mg propiram fumarate, 650 mg aspirin, 60 mg codeine phosphate, and placebo in acute post-impaction dental pain, 159 patients with moderate or severe pain were randomly allocated to the four treatments in this single-dose double-blind, stratified, parallel-group study. A research nurse questioned the patients at 1/2 hour and hourly for 6 hours after medicating. A standard format was used to question subjects about their pain intensity and relief from the starting pain. Propiram, 50 mg, produced a level of analgesia approaching that of 650 mg aspirin in peak effect, total effect, and duration of action and was statistically superior to 60 mg codeine and placebo for every measure of analgesic efficacy. Several mild adverse effects were observed; however, they appeared to be evenly distributed among the active treatments.

To be considered well designed, a study of analgesic efficacy must be conducted under double-blind conditions with patients randomly allocated to each treatment group. Ideally, the study should include both a placebo and an acceptable standard or reference analgesic. Extraneous variables should be kept to a minimum. The most firmly established pain models have used pain caused by cancer, parturition (including episiotomy), surgery postoperatively, oral surgery, and headache. The cancer pain model is most amenable to crossover or multiple-dose studies because of the chronic nature of the pain. Appropriately designed clinical studies have provided conclusive evidence that aspirin and acetaminophen are equianalgesic and, milligram for milligram, equipotent. There also is some evidence that acetaminophen can reduce swelling in inflammatory conditions other than arthritis (eg, in patients who have had oral surgery).

The object of a study was to evaluate the analgesic efficacy of ibuprofen for dental pain. The subjects were outpatients who were undergoing surgical removal of impacted teeth. We compared aspirin, 325 mg; aspirin, 650 mg; ibuprofen, 200 mg; ibuprofen, 400 mg; and placebo. Each patient received a single dose of one of the test medications; there was a minimum of 37 patients in each treatment group. Patients recorded pain intensity before receiving medication; then hourly, for four hours after medication, they recorded pain intensity, amount of relief, and side effects. Time-effect and dose-response curves were generated from the relief and change in pain-intensity scores. First-hour scores, peak scores, and total scores were analyzed. All active medications were significantly better than placebo and the mean effect for ibuprofen was significantly more than for aspirin.

The analgesic efficacy of flurbiprofen 25 mg and 50 mg compared with aspirin 650 mg and placebo (lactose) was evaluated. Subjects were 164 dental outpatients undergoing the surgical removal of impacted teeth. Each subject received a single dose of study medication and was evaluated hourly for six hours. Aspirin was superior to placebo in all measures of analgesic efficacy, and both dosages of flurbiprofen were superior to aspirin.

A double-blind, randomized, parallel group, placebo-controlled study was carried out to compare the safety and efficacy of single doses of suprofen (200 mg and 400 mg) with aspirin (650 mg) and placebo in relieving pain. In patients with pain resulting from periodontal surgery, a single dose of suprofen 200 or 400 mg was significantly better than placebo in reducing pain intensity and providing pain relief. The superiority of both doses of suprofen over placebo was demonstrated in every parameter in which pain intensity or pain relief was calculated. In addition, both doses of suprofen were better than, or at least equivalent to, aspirin 650 mg in every efficacy measure including the patients' overall acceptability of treatment.

The purpose of this study was to characterize the analgesic dose-effect curve of orally administered fendosal, relative to aspirin 650 mg and placebo. A total of 153 patients experiencing moderate to severe pain due to extraction of impacted molar teeth completed this two-part, single-dose, double-blind, randomized trial. In part I, the possible treatments were placebo, aspirin 650 mg, fendosal 100 mg and fendosal 200 mg. In part II, fendosal 400 mg replaced the fendosal 100 mg treatment. A nurse-observer collected subjective reports of pain intensity and relief at 30 minutes and hourly for eight hours. Fendosal 100 mg was not an analgesic dose but 200 and 400 mg were on the ascending portion of the dose-effect curve. Fendosal 200 mg was superior to placebo and about equal to aspirin in total effect but not peak effect. Fendosal 400 mg was statistically superior to both fendosal 200 mg and placebo. Fendosal 400 mg appears to provide analgesia similar to that of aspirin 650 mg but with a substantially longer duration. Only a few mild side effects were reported.

The results from the present studies confirm that indoprofen is an orally effective analgesic drug. Both the 100- and 200-mg dosages of indoprofen demonstrated superior analgesic activity when compared to 600 mg aspirin.