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3. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Garibaldi, Brian T., Albertson, Timothy E., Sandrock, Christian, Lee, Janet S., Looney, Mark R., Tapson, Victor F., Wiysonge, Charles Shey, Velarde, Luis Humberto Anaya, Backenroth, Daniel, Bhushanan, Jisha, Brandenburg, Börries, Cárdenas, Vicky, Chen, Bohang, Chen, Fei, Chetty, Polan, Chu, Pei-Ling, Cooper, Kimberly, Custers, Jerome, Delanghe, Hilde, Duca, Anna, Henrick, Tracy, Juraszek, Jarek, Nalpas, Catherine, Peeters, Monika, Pinheiro, Jose, Roels, Sanne, Ryser, Martin F., Salas, Jose, Santoro Matias, Samantha, Scheys, Ilse, Shetty, Pallavi, Shukarev, Georgi, Stoddard, Jeffrey, Talloen, Willem, Tran, NamPhuong, Vaissiere, Nathalie, van Son-Palmen, Elisabeth, Xu, Jiajun, Goecker, Erin A., Greninger, Alexander L., Jerome, Keith R., Roychoudhury, Pavitra, Takuva, Simbarashe G., Accini Mendoza, Jose Luis, Achtyes, Eric, Ahsan, Habibul, Alhatemi, Azhar, Allen, Nancy, Arribas, Jose R., Bahrami, Ghazaleh, Bailon, Lucia, Bajwa, Ali, Baker, Jonathan, Baron, Mira, Benet, Susana, Berdaï, Driss, Berger, Patrick, Bertoch, Todd, Bethune, Claire, Bevilacqua, Sybille, Biagioni Santos, Maria Silvia, Binnian, Ian, Bisnauthsing, Karen, Boivin, Jean-Marc, Bollen, Hilde, Bonnet, Sandrine, Borobia, Alberto M., Botelho-Nevers, Elisabeth, Bright, Phil, Britten, Vianne, Brown, Claire, Buadi, Amanda, Buntinx, Erik, Burgess, Lesley, Bush, Larry, Capeding, Maria Rosario, Carr, Quito Osuna, Carrasco Mas, Amparo, Catala, Hélène, Cathie, Katrina, Caudill, T. Shawn, Cereto Castro, Fernando, Chau, Kénora, Chavoustie, Steven, Chowdhury, Marie, Chronos, Nicolas, Cicconi, Paola, Cifuentes, Liliana, Cobo, Sara Maria, Collins, Helen, Colton, Hayley, Cuaño, Carlos Rolando G., D'Onofrio, Valentino, Dargan, Paul, Darton, Thomas, Deane, Peter, Del Pozo, Jose Luis, Derdelinckx, Inge, Desai, Amisha, Dever, Michael, Díaz-Pollán, Beatriz, DiBuono, Mark, Doust, Matthew, Duncan, Christopher, Echave-Sustaeta, Jose Maria, Eder, Frank, Ellis, Kimberly, Elzi, Stanton, Emmett, Stevan, Engelbrecht, Johannes, Evans, Mim, Farah, Theo, Felton, Timothy, Ferreira, João Pedro, Floutier, Catherine, Flume, Patrick, Ford, Stacy, Fragoso, Veronica, Freedman, Andrew, Frentiu, Emilia, Galloway, Christopher, Galtier, Florence, Garcia Diaz, Julia, García García, Irene, Garcia, Alcaide, Gardener, Zoe, Gauteul, Pascale, Geller, Steven, Gibson, Andrew, Gillet, Claudia, Girerd, Nicolas, Girodet, Pierre-Olivier, Gler, Maria Tarcela, Glover, Richard, Go, Herschel Don D., Gokani, Karishma, Gonthier, Damien, Green, Christopher, Greenberg, Richard, Griffin, Carl, Grobbelaar, Coert, Guancia, Adonis, Hakkarainen, Gloria, Harris, James, Hassman, Michael, Heimer, Deirdre, Hellstrom-Louw, Elizabeth, Herades, Yoan, Holroyd, Christopher, Hussen, Nazreen, Isidro, Marie Grace Dawn, Jackson, Yvonne, Jain, Manish, João Filho, Esaú Custódio, Johnson, Daniel, Jones, Ben, Joseph, Natasha, Jumeras, Analyn, Junquera, Patricia, Kellett-Wright, Johanna, Kennedy, Patrick, Kilgore, Paul E., Kim, Kenneth, Kimmel, Murray, Konis, George, Kutner, Mark, Lacombe, Karine, Launay, Odile, Lazarus, Rajeka, Lederman, Samuel, Lefebvre, Gigi, Lennon Collins, Katrina, Leroux-Roels, Isabel, Lim, Kenneth Wilson O., Lins, Muriel, Liu, Edward, Llewelyn, Martin, Mahomed, Akbar, Maia, Bernardo Porto, Marín-Candon, Alícia, Martínez-Gómez, Xavier, Martinot, Jean Benoit, Mazzella, Andrea, McCaughan, Frank, McCormack, Louise, McGettigan, John, Mehra, Purvi, Mejeur, Rhonda, Miller, Vicki, Mills, Anthony, Molto Marhuenda, Jose, Moodley, Prebashan, Mora-Rillo, Marta, Mothe, Beatriz, Mullan, Daniel, Munro, Alasdair, Myers, Paul, Nell, Jeremy, Newman Lobato Souza, Tamara, O'Halloran, Jane A., Ochoa Mazarro, Maria Dolores, Oliver, Abigail, Onate Gutierrez, Jose Millan, Ortega, Jessica, Oshita, Masaru, Otero Romero, Susana, Overcash, Jeffrey Scott, Owens, Daniel, Packham, Alice, Pacurar, Mihaela, Paiva de Sousa, Leonardo, Palfreeman, Adrian, Pallares, Christian José, Patel, Rahul, Patel, Suchet, Pelkey, Leslie, Peluso, Denise, Penciu, Florentina, Pinto, S. Jerry, Pounds, Kevin, Pouzar, Joe, Pragalos, Antoinette, Presti, Rachel, Price, David, Qureshi, Ehsaan, Ramalho Madruga, José Valdez, Ramesh, Mayur, Rankin, Bruce, Razat, Béatrice, Riegel Santos, Breno, Riesenberg, Robert, Riffer, Ernie, Roche, Siobhan, Rose, Katie, Rosellini, Pietro, Rossignol, Patrick, Safirstein, Beth, Salazar, Hernan, Sanchez Vallejo, Gregorio, Santhosh, Smrithi, Seco-Meseguer, Enrique, Seep, Michael, Sherry, Emma, Short, Philip, Soentjens, Patrick, Solis, Joel, Soriano Viladomiu, Alejandro, Sorli, Caroline, Spangenthal, Selwyn, Spence, Niamh, Stephenson, Elaine, Strout, Cynthia, Surowitz, Ronald, Taladua, Kristy Michelle, Tellalian, David, Thalamas, Claire, Thiriphoo, Nang, Thomas, Judith, Thomas, Nicholas, Trout, Guillermo, Urroz, Mikel, Veekmans, Bernard, Veekmans, Laurent, Villalobos, Ralph Elvi M., Warren, Sarah, Webster, Brian, White, Alexander, Williams, Gail, Williams, Hayes, Wilson, Barbara, Winston, Alan, Wiselka, Martin, Zervos, Marcus, Hardt, Karin, Vandebosch, An, Sadoff, Jerald, Le Gars, Mathieu, Truyers, Carla, Lowson, David, Van Dromme, Ilse, Vingerhoets, Johan, Kamphuis, Tobias, Scheper, Gert, Ruiz-Guiñazú, Javier, Faust, Saul N, Spinner, Christoph D, Schuitemaker, Hanneke, Van Hoof, Johan, Douoguih, Macaya, and Struyf, Frank

Published
2022
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5. Clinical validation of a fast-acting acetaminophen: a randomized, active and placebo controlled dental pain study.

Author

Myers, Andrew, Bertoch, Todd, Zhang, Paul, and Cooper, Stephen A.

Subjects
*TOOTHACHE, *DRUG delivery systems, *POSTOPERATIVE pain, *ANALGESIA, *ACETAMINOPHEN, *PAIN management
Abstract

To address the need for faster pain relief of over-the-counter (OTC) analgesic users, a novel drug delivery technology was developed to achieve faster absorption of orally administered acetaminophen with the goal of delivering earlier onset of pain relief. Previous development studies suggested that a 1000 mg dose of this fast-acting acetaminophen (FA-acetaminophen) formulation provided faster absorption and onset of action versus, commercially available OTC fast-acting analgesics, 1000 mg of extra-strength acetaminophen (ES-acetaminophen) or 400 mg of liquid-filled ibuprofen capsules (LG-ibuprofen). This study was designed as the definitive trial evaluating the onset of pain relief of FA-acetaminophen versus these same OTC comparators. This single-dose, randomized, double-blind, placebo- and active-controlled clinical trial compared analgesic onset, overall efficacy, and safety of FA-acetaminophen 1000 mg, ES-acetaminophen 1000 mg, LG-ibuprofen 400 mg, and placebo over 4 h in a postsurgical dental pain model. Following removal of 3 to 4 impacted third molars, 664 subjects with moderate-to-severe pain were randomized in a 4:4:2:1 ratio to FA-acetaminophen (249), ES-acetaminophen (232), LG-ibuprofen (124), or placebo (59). Mean age was 18.9 years; 45.5% were male; 57.5% had severe baseline pain intensity. Subjects stopped a first stopwatch if/when they had perceptible pain relief and a second stopwatch if/when their pain relief became meaningful to them. Pain intensity difference (PID) and pain relief (PAR) were obtained using an 11-point numerical rating scale. FA-acetaminophen 1000 mg had faster median time to onset of pain relief (15.7 min) compared to ES-acetaminophen 1000 mg (20.2 min, p = 0.035), LG-ibuprofen 400 mg (23.2 min, p < 0.001), and placebo (non-estimable), statistically greater mean PAR and PID scores than other treatment groups at 15 and 30 min, and a statistically greater percentage of subjects with confirmed perceptible pain relief at 15 and 20 min. At 25 min, FA-acetaminophen 1000 mg had a statistically significantly greater percentage of subjects with confirmed perceptible pain relief than LG-ibuprofen 400 mg and placebo. No clinically significant adverse events were reported. This study supports previous studies, demonstrating faster onset of analgesia with FA-acetaminophen 1000 mg compared to OTC ES-acetaminophen 1000 mg and OTC LG-ibuprofen 400 mg. NCT03224403 [ABSTRACT FROM AUTHOR]

Published
2024
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6. Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-Blind, Controlled, Phase 3 Noninferiority Trial

Author

Gan, Tong J., primary, Bertoch, Todd, additional, Habib, Ashraf S., additional, Yan, Pangke, additional, Zhou, Rong, additional, Lai, Yu-Ling, additional, Liu, Xiao, additional, Essandoh, Michael, additional, Daley, William L., additional, and Gelb, Adrian W., additional

Published
2023
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7. Selective Inhibition of Na V 1.8 with VX-548 for Acute Pain

Author

Jones, Jim, primary, Correll, Darin J., additional, Lechner, Sandra M., additional, Jazic, Ina, additional, Miao, Xiaopeng, additional, Shaw, David, additional, Simard, Christopher, additional, Osteen, Jeremiah D., additional, Hare, Brian, additional, Beaton, Alina, additional, Bertoch, Todd, additional, Buvanendran, Asokumar, additional, Habib, Ashraf S., additional, Pizzi, Lois J., additional, Pollak, Richard A., additional, Weiner, Scott G., additional, Bozic, Carmen, additional, Negulescu, Paul, additional, and White, Paul F., additional

Published
2023
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9. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Hardt, Karin, primary, Vandebosch, An, additional, Sadoff, Jerald, additional, Le Gars, Mathieu, additional, Truyers, Carla, additional, Lowson, David, additional, Van Dromme, Ilse, additional, Vingerhoets, Johan, additional, Kamphuis, Tobias, additional, Scheper, Gert, additional, Ruiz-Guiñazú, Javier, additional, Faust, Saul N, additional, Spinner, Christoph D, additional, Schuitemaker, Hanneke, additional, Van Hoof, Johan, additional, Douoguih, Macaya, additional, Struyf, Frank, additional, Garibaldi, Brian T., additional, Albertson, Timothy E., additional, Sandrock, Christian, additional, Lee, Janet S., additional, Looney, Mark R., additional, Tapson, Victor F., additional, Wiysonge, Charles Shey, additional, Velarde, Luis Humberto Anaya, additional, Backenroth, Daniel, additional, Bhushanan, Jisha, additional, Brandenburg, Börries, additional, Cárdenas, Vicky, additional, Chen, Bohang, additional, Chen, Fei, additional, Chetty, Polan, additional, Chu, Pei-Ling, additional, Cooper, Kimberly, additional, Custers, Jerome, additional, Delanghe, Hilde, additional, Duca, Anna, additional, Henrick, Tracy, additional, Juraszek, Jarek, additional, Nalpas, Catherine, additional, Peeters, Monika, additional, Pinheiro, Jose, additional, Roels, Sanne, additional, Ryser, Martin F., additional, Salas, Jose, additional, Santoro Matias, Samantha, additional, Scheys, Ilse, additional, Shetty, Pallavi, additional, Shukarev, Georgi, additional, Stoddard, Jeffrey, additional, Talloen, Willem, additional, Tran, NamPhuong, additional, Vaissiere, Nathalie, additional, van Son-Palmen, Elisabeth, additional, Xu, Jiajun, additional, Goecker, Erin A., additional, Greninger, Alexander L., additional, Jerome, Keith R., additional, Roychoudhury, Pavitra, additional, Takuva, Simbarashe G., additional, Accini Mendoza, Jose Luis, additional, Achtyes, Eric, additional, Ahsan, Habibul, additional, Alhatemi, Azhar, additional, Allen, Nancy, additional, Arribas, Jose R., additional, Bahrami, Ghazaleh, additional, Bailon, Lucia, additional, Bajwa, Ali, additional, Baker, Jonathan, additional, Baron, Mira, additional, Benet, Susana, additional, Berdaï, Driss, additional, Berger, Patrick, additional, Bertoch, Todd, additional, Bethune, Claire, additional, Bevilacqua, Sybille, additional, Biagioni Santos, Maria Silvia, additional, Binnian, Ian, additional, Bisnauthsing, Karen, additional, Boivin, Jean-Marc, additional, Bollen, Hilde, additional, Bonnet, Sandrine, additional, Borobia, Alberto M., additional, Botelho-Nevers, Elisabeth, additional, Bright, Phil, additional, Britten, Vianne, additional, Brown, Claire, additional, Buadi, Amanda, additional, Buntinx, Erik, additional, Burgess, Lesley, additional, Bush, Larry, additional, Capeding, Maria Rosario, additional, Carr, Quito Osuna, additional, Carrasco Mas, Amparo, additional, Catala, Hélène, additional, Cathie, Katrina, additional, Caudill, T. Shawn, additional, Cereto Castro, Fernando, additional, Chau, Kénora, additional, Chavoustie, Steven, additional, Chowdhury, Marie, additional, Chronos, Nicolas, additional, Cicconi, Paola, additional, Cifuentes, Liliana, additional, Cobo, Sara Maria, additional, Collins, Helen, additional, Colton, Hayley, additional, Cuaño, Carlos Rolando G., additional, D'Onofrio, Valentino, additional, Dargan, Paul, additional, Darton, Thomas, additional, Deane, Peter, additional, Del Pozo, Jose Luis, additional, Derdelinckx, Inge, additional, Desai, Amisha, additional, Dever, Michael, additional, Díaz-Pollán, Beatriz, additional, DiBuono, Mark, additional, Doust, Matthew, additional, Duncan, Christopher, additional, Echave-Sustaeta, Jose Maria, additional, Eder, Frank, additional, Ellis, Kimberly, additional, Elzi, Stanton, additional, Emmett, Stevan, additional, Engelbrecht, Johannes, additional, Evans, Mim, additional, Farah, Theo, additional, Felton, Timothy, additional, Ferreira, João Pedro, additional, Floutier, Catherine, additional, Flume, Patrick, additional, Ford, Stacy, additional, Fragoso, Veronica, additional, Freedman, Andrew, additional, Frentiu, Emilia, additional, Galloway, Christopher, additional, Galtier, Florence, additional, Garcia Diaz, Julia, additional, García García, Irene, additional, Garcia, Alcaide, additional, Gardener, Zoe, additional, Gauteul, Pascale, additional, Geller, Steven, additional, Gibson, Andrew, additional, Gillet, Claudia, additional, Girerd, Nicolas, additional, Girodet, Pierre-Olivier, additional, Gler, Maria Tarcela, additional, Glover, Richard, additional, Go, Herschel Don D., additional, Gokani, Karishma, additional, Gonthier, Damien, additional, Green, Christopher, additional, Greenberg, Richard, additional, Griffin, Carl, additional, Grobbelaar, Coert, additional, Guancia, Adonis, additional, Hakkarainen, Gloria, additional, Harris, James, additional, Hassman, Michael, additional, Heimer, Deirdre, additional, Hellstrom-Louw, Elizabeth, additional, Herades, Yoan, additional, Holroyd, Christopher, additional, Hussen, Nazreen, additional, Isidro, Marie Grace Dawn, additional, Jackson, Yvonne, additional, Jain, Manish, additional, João Filho, Esaú Custódio, additional, Johnson, Daniel, additional, Jones, Ben, additional, Joseph, Natasha, additional, Jumeras, Analyn, additional, Junquera, Patricia, additional, Kellett-Wright, Johanna, additional, Kennedy, Patrick, additional, Kilgore, Paul E., additional, Kim, Kenneth, additional, Kimmel, Murray, additional, Konis, George, additional, Kutner, Mark, additional, Lacombe, Karine, additional, Launay, Odile, additional, Lazarus, Rajeka, additional, Lederman, Samuel, additional, Lefebvre, Gigi, additional, Lennon Collins, Katrina, additional, Leroux-Roels, Isabel, additional, Lim, Kenneth Wilson O., additional, Lins, Muriel, additional, Liu, Edward, additional, Llewelyn, Martin, additional, Mahomed, Akbar, additional, Maia, Bernardo Porto, additional, Marín-Candon, Alícia, additional, Martínez-Gómez, Xavier, additional, Martinot, Jean Benoit, additional, Mazzella, Andrea, additional, McCaughan, Frank, additional, McCormack, Louise, additional, McGettigan, John, additional, Mehra, Purvi, additional, Mejeur, Rhonda, additional, Miller, Vicki, additional, Mills, Anthony, additional, Molto Marhuenda, Jose, additional, Moodley, Prebashan, additional, Mora-Rillo, Marta, additional, Mothe, Beatriz, additional, Mullan, Daniel, additional, Munro, Alasdair, additional, Myers, Paul, additional, Nell, Jeremy, additional, Newman Lobato Souza, Tamara, additional, O'Halloran, Jane A., additional, Ochoa Mazarro, Maria Dolores, additional, Oliver, Abigail, additional, Onate Gutierrez, Jose Millan, additional, Ortega, Jessica, additional, Oshita, Masaru, additional, Otero Romero, Susana, additional, Overcash, Jeffrey Scott, additional, Owens, Daniel, additional, Packham, Alice, additional, Pacurar, Mihaela, additional, Paiva de Sousa, Leonardo, additional, Palfreeman, Adrian, additional, Pallares, Christian José, additional, Patel, Rahul, additional, Patel, Suchet, additional, Pelkey, Leslie, additional, Peluso, Denise, additional, Penciu, Florentina, additional, Pinto, S. Jerry, additional, Pounds, Kevin, additional, Pouzar, Joe, additional, Pragalos, Antoinette, additional, Presti, Rachel, additional, Price, David, additional, Qureshi, Ehsaan, additional, Ramalho Madruga, José Valdez, additional, Ramesh, Mayur, additional, Rankin, Bruce, additional, Razat, Béatrice, additional, Riegel Santos, Breno, additional, Riesenberg, Robert, additional, Riffer, Ernie, additional, Roche, Siobhan, additional, Rose, Katie, additional, Rosellini, Pietro, additional, Rossignol, Patrick, additional, Safirstein, Beth, additional, Salazar, Hernan, additional, Sanchez Vallejo, Gregorio, additional, Santhosh, Smrithi, additional, Seco-Meseguer, Enrique, additional, Seep, Michael, additional, Sherry, Emma, additional, Short, Philip, additional, Soentjens, Patrick, additional, Solis, Joel, additional, Soriano Viladomiu, Alejandro, additional, Sorli, Caroline, additional, Spangenthal, Selwyn, additional, Spence, Niamh, additional, Stephenson, Elaine, additional, Strout, Cynthia, additional, Surowitz, Ronald, additional, Taladua, Kristy Michelle, additional, Tellalian, David, additional, Thalamas, Claire, additional, Thiriphoo, Nang, additional, Thomas, Judith, additional, Thomas, Nicholas, additional, Trout, Guillermo, additional, Urroz, Mikel, additional, Veekmans, Bernard, additional, Veekmans, Laurent, additional, Villalobos, Ralph Elvi M., additional, Warren, Sarah, additional, Webster, Brian, additional, White, Alexander, additional, Williams, Gail, additional, Williams, Hayes, additional, Wilson, Barbara, additional, Winston, Alan, additional, Wiselka, Martin, additional, and Zervos, Marcus, additional

Published
2022
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11. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial.

Author

Cooper, Stephen A., Desjardins, Paul J, Bertoch, Todd, Paredes-Diaz, Alberto, Troullos, Emanuel, Tajaddini, Azita, Centofanti, Robert, An, Robert, and Morella, Donna

Abstract

Objectives: Opioid/acetaminophen combinations may be overly prescribed in many post-surgical situations where a non-steroidal anti-inflammatory drug with equal or greater efficacy, fewer central nervous system side effects, and no risk for opioid abuse could be substituted. We compared a single, non-prescription dose of naproxen sodium 440 mg (NapS) against hydrocodone plus acetaminophen 10/650 mg (HYD+APAP) in post-impaction surgery pain.Methods: Single-center, randomized, double-blind, placebo-controlled study in moderate-severe pain after surgical removal of impacted third molars (ClinicalTrials.gov: NCT04307940). Patients (n = 212) received NapS, HYD+APAP, or placebo and were assessed over 12 hours. Primary endpoint: summed pain intensity difference from 0 to 12 hours (SPID0-12). Secondary endpoints: pain intensity, pain relief, time to rescue medication, duration of pain at least half gone. Others: onset of pain relief, global assessment of treatment, adverse events.Results: All 221 randomized patients formed the safety population and were included in the intention-to-treat sensitivity analysis. Nine patients discontinued treatment or had protocol violations, and 212 patients were included in the per-protocol, primary efficacy population. Both active treatments were significantly more effective than placebo. NapS was significantly more effective than HYD+APAP regarding SPID0-12 (p = 0.01; primary endpoint), total pain relief (0-6 and 0-12 hours; p < 0.05), time to rescue medication (p < 0.001), and duration of pain at least half gone (p < 0.001). HYD+APAP was not statistically superior to NapS for any endpoint. More adverse events were reported with HYD+APAP (n = 63) than NapS (n = 2) and placebo (n = 20), including nausea, vomiting, and dizziness.Conclusion: In moderate-to-severe postsurgical dental pain, a single dose of NapS was at least as effective as HYD+APAP in the early hours, significantly more effective at reducing pain intensity and providing greater pain relief over 12 hours, and was better tolerated. When not contraindicated, NapS should be considered a preferred alternative to opioid combinations for acute pain. (ClinicalTrials.gov, Identifier: NCT04307940; https://clinicaltrials.gov/ct2/show/NCT04307940). [ABSTRACT FROM AUTHOR]

Published
2022
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12. Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study.

Author

Singla, Neil, Bertoch, Todd, Shenoy, Srinivas, and Munjal, Sagar

Subjects
*TOOTHACHE, *OPERATIVE dentistry, *DENTAL extraction, *PATIENT satisfaction, *ANALGESIA, *THIRD molars, *PAIN management, *MOLARS
Abstract

Abstract: The analgesic efficacy and safety of DFN-15, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery. In this randomized, double-blind, placebo-controlled, dose-ranging study, 120 otherwise healthy adults who underwent the extraction of bilateral impacted mandibular third molar teeth and experienced moderate to severe pain postsurgery were randomly assigned, in a 1:1:1:1 ratio, to receive one dose of either placebo or DFN-15 at 3 doses: 62.5, 125, and 250 mg. Participants were evaluated at prespecified time points over 8 hours after study drug administration, using several instruments, including the 11-point Numerical Pain Rating Scale, 5-point Pain Relief Scale, and 5-point Treatment Satisfaction Scale. Rescue analgesic (oxycodone / acetaminophen) was permitted. The primary endpoint was the summed pain intensity difference (SPID) over the 6-hour postdose period (SPID6), which was compared between each DFN-15 dose and placebo using analysis of covariance. Other assessments of pain relief, use of rescue medication, and safety were also analyzed. All 3 doses of DFN-15 were significantly superior to placebo in SPID6 (least square mean difference over placebo: -756.6, -1120.7, and -1355.1, P < 0.0001 for all comparisons). In addition, DFN-15 was generally superior to placebo in other endpoints, including reduction of pain intensity, speed and magnitude of pain relief, treatment satisfaction, and rescue medication use. DFN-15 was similar to placebo in the incidence of adverse events with no apparent dose-related effects. [ABSTRACT FROM AUTHOR]

Published
2022
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