Briggs W. Morrison

Merck, Whitehouse Station, New Jersey, United States

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Publications (10)64.78 Total impact

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    ABSTRACT: Rofecoxib and celecoxib, selective cyclooxygenase-2 inhibitors, have analgesic efficacy similar to that of nonselective nonsteroidal anti-inflammatory drugs. This study was designed to confirm earlier findings that the overall analgesic efficacy of rofecoxib 50 mg was superior to that of celecoxib 200 mg and to extend the comparison to include celecoxib 400 mg. In this single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study, patients who experienced moderate or severe pain after surgical extraction of at least 2 third molars received a single oral dose of either rofecoxib 50 mg, celecoxib 400 mg, celecoxib 200 mg, ibuprofen 400 mg, or placebo. Patients recorded scores of pain intensity, pain relief, and global assessment at prespecified time intervals throughout the 24-hour period after dosing. The end points were total pain relief (TOPAR) score over 8 hours (TOPAR8; primary end point), TOPAR score over 12 hours (TOPAR12), sum of pain intensity difference (SPID) over 8 and 12 hours (SPID8 and SPID12), patient's global assessment of study drug at 8 hours, time to confirmed perceptible pain relief (ie, time to onset of analgesic effect), peak pain intensity difference (PID), peak pain relief, time to first dose of rescue medication (ie, duration of analgesic effect), and percentage of patients using rescue medication. A total of 482 patients (358 females, 124 males; mean age, 22.1 years) were enrolled. Rofecoxib 50 mg (n = 151 patients) demonstrated significantly greater overall analgesic efficacy compared with celecoxib 400 mg (n = 151), as measured by TOPAR8 (least squares mean [SE] 17.2 [0.8] vs 15.0 [0.8]; P < 0.05) and TOPAR12 (25.3 [1.2] vs 21.0 [1.2]; P < 0.05), as well as a significantly longer duration of analgesic effect (P < 0.05). Time to onset of analgesic effect and peak analgesic effect were similar for rofecoxib 50 mg and celecoxib 400 mg. Rofecoxib also showed significantly greater overall analgesic efficacy than did celecoxib 200 mg (n = 90), including greater TOPAR8 scores (17.2 [0.8] vs 11.5 [1.1]; P < 0.001), faster onset of analgesic effect (P < 0.001), greater peak analgesic effect (P < 0.001 for peak pain relief and peak PID), and longer duration of analgesic effect (P < 0.001). The overall analgesic efficacy of rofecoxib 50 mg was similar to that of ibuprofen 400 mg (n = 45), except that the duration of analgesic effect of rofecoxib 50 mg was significantly longer (P < 0.001). All active treatments produced significantly greater overall analgesic efficacy compared with that of placebo (P < 0.001 for all scores [TOPAR8, TOPAR12, SPID8, SPID12, and patient's global assessment] for all study drugs). The adverse-events (AE) profile was generally similar in all treatment groups. The 3 most common AEs were nausea, postextraction alveolitis, and vomiting. In this study, rofecoxib 50 mg provided generally superior overall analgesic efficacy compared with that of celecoxib 400 and 200 mg, including a significantly longer duration of analgesic effect. The overall analgesic efficacy of rofecoxib 50 mg was generally similar to that of ibuprofen 400 mg, except for a significantly longer duration of analgesic effect.
    No preview · Article · Nov 2002 · Clinical Therapeutics
  • Briggs W. Morrison · James Fricke · Jean Brown · Weiying Yuan · Paul Kotey · Donald Mehlisch
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    ABSTRACT: Rofecoxib, which specifically inhibits cyclooxygenase-2, is indicated for relief of the signs and symptoms of osteoarthritis and for the management of acute pain in adults. The authors present an overview of six placebo-controlled trials designed to evaluate the single-dose analgesic efficacy of a range of doses of rofecoxib in the treatment of postoperative dental pain. The six studies included doses of rofecoxib ranging from 7.5 to 500 milligrams. Maximal analgesic doses of a nonsteroidal anti-inflammatory drug, or NSAID, either naproxen sodium (550 mg) or ibuprofen (400 mg), were used as active comparators in each study. Analgesic efficacy was assessed with the use of validated self-administered questionnaires. The primary endpoint in each study was the total pain relief over the eight-hour postdose period. Additional endpoints were used to characterize the onset of analgesia and peak analgesic effect. The results of these studies demonstrated that the efficacy of rofecoxib was dose-related, with 50 mg being consistently more effective than placebo for all measures of analgesic efficacy. Moreover, 50 mg was the lowest dose that reproducibly demonstrated an analgesic effect comparable to the effect of maximum single analgesic doses of NSAIDs. The results of these studies support the recommended dose of 50 mg of rofecoxib once daily for the management of pain. Rofecoxib, at a dose of 50 mg, is effective in the management of postoperative dental pain.
    No preview · Article · Jan 2001 · Journal of the American Dental Association (1939)
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    ABSTRACT: Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). It is not known whether a specific inhibitor of COX-2 will provide efficacy in osteoarthritis (OA) comparable with NSAIDs. Therefore, we compared the efficacy and safety of the rofecoxib, which specifically inhibits COX-2, with those of the NSAID ibuprofen in patients with OA. To compare the clinical efficacy and tolerability of rofecoxib (12.5 and 25 mg once daily) with ibuprofen (800 mg 3 times daily). A randomized, double-blind trial of 809 adults with OA was conducted. Patients with OA in whom the knee or hip was the primary source of pain were randomized to 1 of 4 treatment groups on demonstration of disease activity: placebo; rofecoxib, 12.5 or 25 mg once daily; or ibuprofen, 800 mg 3 times daily. Clinical efficacy and safety were monitored during a 6-week treatment period. Both doses of rofecoxib demonstrated efficacy clinically comparable with ibuprofen as assessed by 3 primary end points (pain walking on a flat surface [Western Ontario and McMaster Universities Osteoarthritis Index], patient global assessment of response to therapy, and investigator global assessment of disease status) according to predefined comparability criteria. Both rofecoxib doses and the ibuprofen dose provided significantly (P<.001) greater efficacy than placebo on all primary end points. Results from secondary end points were consistent with those of the primary end points. All treatments were well tolerated; the overall incidence rates of clinical adverse experiences were not significantly different (P>.05) among the treatment groups. Rofecoxib was well tolerated and provided clinical efficacy comparable with a high dose of the NSAID ibuprofen.
    No preview · Article · Jun 2000 · Archives of Internal Medicine
  • B W Morrison · S E Daniels · P Kotey · N Cantu · B Seidenberg
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    ABSTRACT: To determine whether rofecoxib is effective for treating primary dysmenorrhea and whether cyclooxygenase-2 is involved in the pathophysiology of primary dysmenorrhea. A double-masked, randomized, placebo and active-comparator-controlled clinical trial including 127 subjects with histories of primary dysmenorrhea was conducted in an outpatient clinical research center. Subjects were randomly assigned to placebo, rofecoxib 25 or 50 mg followed by 25 mg every 24 hours as needed, or naproxen sodium 550 mg every 12 hours as needed for up to 3 days. Subjects took all four treatments in a balanced, complete-block, crossover design. Measurements included self-administered questionnaires of analgesic efficacy, spontaneous reports of adverse experiences, physical examinations, and laboratory safety tests. Rofecoxib 25 and 50 mg provided analgesic efficacy greater than placebo (P < or = .006) for the primary endpoint of total pain relief over the first 8 hours. For other efficacy endpoints (sum of the pain intensity difference over the first 8 hours, subject's global evaluation, peak pain relief, peak pain intensity difference, and time to remedication) both doses of rofecoxib were better than placebo (P < or = .006) and were not distinguishable from naproxen sodium for all efficacy endpoints. All treatments were well tolerated. Rofecoxib effectively treated primary dysmenorrhea, and cyclooxygenase-2-derived prostanoids play a role in the pathophysiology of primary dysmenorrhea.
    No preview · Article · Nov 1999 · Obstetrics and Gynecology
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    ABSTRACT: To determine the efficacy and safety of the cyclooxygenase 2 (COX-2) specific inhibitor, rofecoxib in patients with osteoarthritis (OA) of the knee. Rofecoxib, 25 mg or 125 mg once daily, was compared with placebo in a 6 week, double blind, parallel group, randomized, multicenter study of 219 patients with knee OA. Both doses of rofecoxib produced clinically significant improvement as assessed by primary (e.g., WOMAC Pain Subscale 0-100 mm, decrease from baseline: placebo: 7.1 mm; rofecoxib 25 mg: 28.1 mm, rofecoxib 125 mg: 28.0 mm; p < 0.001 rofecoxib vs placebo) and secondary efficacy (p < 0.05) criteria compared with placebo. Clinical improvement with the 25 mg dose was similar to that with the 125 mg dose. Both rofecoxib doses were generally well tolerated. Specific inhibition of COX-2 by 25 and 125 mg rofecoxib, administered once daily, resulted in clinically meaningful improvements in patients with OA. This study confirms that COX-2 derived prostanoids are important clinical mediators of pain and other symptoms of knee OA and that inhibition of COX-1 is not required to provide clinical benefit.
    No preview · Article · Nov 1999 · The Journal of Rheumatology
  • B W Morrison · S Christensen · W Yuan · J Brown · S Amlani · B Seidenberg
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    ABSTRACT: Previous data have suggested that rofecoxib, a cyclooxygenase (COX)-2-specific inhibitor, had analgesic effects similar to those of the nonsteroidal anti-inflammatory drugs when tested in the post-dental surgery pain model. The objective of this parallel-group, double-masked, randomized, placebo- and active comparator-controlled clinical trial was to assess more fully the analgesic efficacy of rofecoxib in the treatment of postoperative dental pain. After dental surgery, 151 patients (50.3% women; mean age, 18.3 years; 93.4% white) experiencing moderate-to-severe pain were to receive a single dose of placebo, rofecoxib 50 mg, or ibuprofen 400 mg. Analgesic efficacy was assessed for up to 24 hours postdose using self-administered questionnaires. Tolerability was assessed using spontaneous reports of adverse experiences, physical findings, and laboratory measurements. The results of this study demonstrated that rofecoxib 50 mg was more effective than placebo on all measures of analgesic efficacy. Rofecoxib 50 mg exhibited overall analgesic effects, onset of analgesia, and peak analgesic effects that were not significantly different from those of ibuprofen 400 mg, with a significantly longer duration of action (P < 0.05). We concluded that rofecoxib was efficacious in the treatment of postoperative dental pain and that COX-2-derived prostanoids play a role in treatment of the pain associated with dental surgery.
    No preview · Article · Jul 1999 · Clinical Therapeutics
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    ABSTRACT: MK-966 has been characterized as a specific inhibitor of COX-2. This study compared the analgesic effects of a single oral dose of MK-966 (V) 12.5, 25, 50mg, placebo, and naproxen sodium (NP) 550 mg in the treatment of postoperative dental pain. A double-blind, randomized, placebo-controlled study was conducted in 331 patients. For the primary endpoint, TOPAR 8-hours, all doses of V were superior to placebo (p≤0.009); 25 and 50 were superior to 12.5 (p<0.001). For other endpoints (SPID8, Patient's Global Evaluation, stopwatch time to meaningful relief, peak pain relief, peak PID, time to remedication) all doses of V were superior to placebo (p≤0.009); 25 and 50 were superior to 12.5 (p≤0.006). V 25 was numerically less effective than 50. V 50 mg was indistinguishable from NP for all end points. All treatments were well tolerated. Conclusion: 1) MK-966 50 mg provided analgesic efficacy generally similar to naproxen sodium 550 mg in this model.
    No preview · Article · Feb 1999 · Clinical Pharmacology &#38 Therapeutics
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    ABSTRACT: MK-966 has been characterized as a specific inhibitor of COX-2. This study compared the analgesic effects of MK-966 25 or 50 mg as an initial dose followed by 25 daily, placebo all doses, and naproxen sodium 550 mg (NP) q12 hrs in the treatment of primary dysmenorrhea. A double-blind, randomized, complete block crossover, placebo-controlled study was conducted in 127 patients. For the primary endpoint, TOPAR 8 hours, both doses of MK-966 were superior to placebo (p<0.001). For other endpoints (SPID 8, Patient's Global Evaluation, peak pain relief, peak PID, time to remedication, ranking of study drugs across cycles) both doses of MK-966 were better than placebo (p≤0.003); time to PID ≥1 was marginally better with MK-966 50 (p=0.072) compared to placebo. MK-966 was not distinguishable from NP for all end points. All treatments were well tolerated. Conclusion: 1) MK-966 25 or 50 mg as an initial dose followed by 25 mg daily provides analgesic efficacy generally similar to NP in this model.
    Preview · Article · Feb 1999 · Clinical Pharmacology &#38 Therapeutics
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    ABSTRACT: MK-0966 has been characterized as a specific inhibitor of COX-2. This study compared the analgesic effects of a single oral dose of MK-0966 50 mg, placebo, and Ibuprofen 400 mg in the treatment of postoperative dental pain. A double-blind, randomized, placebo-controlled study was conducted in 151 patients. For the primary endpoint, TOPAR 8-hours, MK-0966 50 mg was superior to placebo (p<0.001). For all other endpoints (SPID8 [p<0.001]. Patient Global Evaluation [p<0.001], stopwatch time to confirmed perceptible relief [0.007], peak pain relief [p<0.001], peak PID [p<0.001], %remedicated within 24 hours [p<0.001], time to remedication [p<0.001]) MK-0966 50 mg was superior to placebo, MK-0966 50 mg was not distinguishable from Ibuprofen 400 mg for all endpoints except those assessing duration (p≤0.03 favoring MK-0966). All treatments were well tolerated. Conclusion: MK-0966 50 mg provided analgesic efficacy generally similar to Ibuprofen 400 mg but with a longer duration of action in this model.
    No preview · Article · Jan 1999 · Clinical Pharmacology &#38 Therapeutics
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    ABSTRACT: MK-0966 has been characterized as a specific inhibitor of COX-2. This study compared the analgesic effects of ML-0966 50 mg as an initial dose followed by 25 mg daily prn, placebo all doses, and naproxen sodium (NP) 550 mg q12 hrs prn in the treatment of primary dysmenorrhea. A double-blind, randomized, complete block crossover, placebo-controlled study was conducted in 63 patients. For the primary endpoint, TOTPAR 8-hours, MK-0966 was superior to placebo (p<0.002). For other endpoints (SPID8, peak pain relief, peak PID, time to remedication, ranking of study drugs across cycles) MK-0966 was better than placebo (p<0.009); time to PID ≥1 was marginally better with MK-0966 (p+0.067) compared to placebo. MK-0966 was not significantly distinguishable from NP for all endpoints. All treatments were well tolerated. Conclusions: 1) MK-0966 50 mg provided analgesic efficacy generally similar to NP in this model 2) COX-2 derived prostanoids are involved in the pain of primary dysmenorrhea.
    No preview · Article · Jan 1999 · Clinical Pharmacology &#38 Therapeutics