diclofenac has been researched along with Acute Pain in 40 studies
Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.
Acute Pain: Intensely discomforting, distressful, or agonizing sensation associated with trauma or disease, with well-defined location, character, and timing.
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 27 (67.50) | 24.3611 |
| 2020's | 13 (32.50) | 2.80 |
| Authors | Studies |
|---|---|
| Amelin, AV | 1 |
| Tereshchenko, NM | 1 |
| Gotovchikov, AA | 1 |
| Jones, CA | 1 |
| Hoehler, FK | 1 |
| Frangione, V | 1 |
| Ledesma, G | 1 |
| Wisman, PP | 1 |
| Jones, C | 1 |
| Slawson, DC | 1 |
| Kiselev, DV | 1 |
| Lavrukhin, VV | 1 |
| Pabst, H | 2 |
| Gruber, G | 1 |
| Picciotto, R | 1 |
| Barbaro, B | 1 |
| Giordan, N | 1 |
| Iliopoulos, K | 1 |
| Koufaki, P | 1 |
| Tsilikas, S | 1 |
| Avramidis, K | 1 |
| Tsagkalis, A | 1 |
| Mavragani, C | 1 |
| Zintzaras, E | 1 |
| Marin, T | 1 |
| Busse, JW | 1 |
| Sadeghirad, B | 1 |
| Oparin, Y | 1 |
| Chen, E | 1 |
| Goshua, A | 1 |
| May, C | 1 |
| Hong, PJ | 1 |
| Agarwal, A | 1 |
| Chang, Y | 1 |
| Ross, SA | 1 |
| Emary, P | 1 |
| Florez, ID | 1 |
| Noor, ST | 1 |
| Yao, W | 1 |
| Lok, A | 1 |
| Ali, SH | 1 |
| Craigie, S | 1 |
| Couban, R | 1 |
| Morgan, RL | 1 |
| Culig, K | 1 |
| Brar, S | 1 |
| Akbari-Kelachayeh, K | 1 |
| Pozdnyakov, A | 1 |
| Shergill, Y | 1 |
| Sivananthan, L | 1 |
| Zihayat, B | 1 |
| Das, A | 1 |
| Guyatt, GH | 1 |
| Nese, M | 1 |
| Riboli, G | 1 |
| Brighetti, G | 1 |
| Sassi, V | 1 |
| Camela, E | 1 |
| Caselli, G | 1 |
| Sassaroli, S | 1 |
| Borlimi, R | 1 |
| Aucoin, M | 1 |
| Cooley, K | 1 |
| Saunders, PR | 1 |
| Carè, J | 1 |
| Anheyer, D | 1 |
| Medina, DN | 1 |
| Cardozo, V | 1 |
| Remy, D | 1 |
| Hannan, N | 1 |
| Garber, A | 1 |
| Velayos, M | 1 |
| Muñoz-Serrano, AJ | 1 |
| Estefanía-Fernández, K | 1 |
| Sarmiento Caldas, MC | 1 |
| Moratilla Lapeña, L | 1 |
| López-Santamaría, M | 1 |
| López-Gutiérrez, JC | 1 |
| Li, J | 1 |
| Zhang, J | 1 |
| Shen, S | 1 |
| Zhang, B | 2 |
| Yu, WW | 1 |
| Toyoda, H | 1 |
| Huang, DQ | 1 |
| Le, MH | 1 |
| Nguyen, MH | 1 |
| Huang, R | 1 |
| Zhu, L | 1 |
| Wang, J | 6 |
| Xue, L | 1 |
| Liu, L | 2 |
| Yan, X | 2 |
| Huang, S | 1 |
| Li, Y | 6 |
| Xu, T | 1 |
| Li, C | 2 |
| Ji, F | 1 |
| Ming, F | 1 |
| Zhao, Y | 2 |
| Cheng, J | 1 |
| Wang, Y | 3 |
| Zhao, H | 1 |
| Hong, S | 1 |
| Chen, K | 2 |
| Zhao, XA | 1 |
| Zou, L | 1 |
| Sang, D | 1 |
| Shao, H | 1 |
| Guan, X | 1 |
| Chen, X | 2 |
| Chen, Y | 4 |
| Wei, J | 1 |
| Zhu, C | 1 |
| Wu, C | 1 |
| Moore, HB | 1 |
| Barrett, CD | 1 |
| Moore, EE | 1 |
| Jhunjhunwala, R | 1 |
| McIntyre, RC | 1 |
| Moore, PK | 1 |
| Hajizadeh, N | 1 |
| Talmor, DS | 1 |
| Sauaia, A | 1 |
| Yaffe, MB | 1 |
| Liu, C | 3 |
| Lin, Y | 1 |
| Dong, Y | 1 |
| Wu, Y | 1 |
| Bao, Y | 1 |
| Yan, H | 2 |
| Ma, J | 1 |
| Fernández-Cuadros, ME | 1 |
| Albaladejo-Florín, MJ | 1 |
| Álava-Rabasa, S | 1 |
| Usandizaga-Elio, I | 1 |
| Martinez-Quintanilla Jimenez, D | 1 |
| Peña-Lora, D | 1 |
| Neira-Borrajo, I | 1 |
| López-Muñoz, MJ | 1 |
| Rodríguez-de-Cía, J | 1 |
| Pérez-Moro, OS | 1 |
| Abdallah, M | 1 |
| Alsaleh, H | 1 |
| Baradwan, A | 1 |
| Alfawares, R | 1 |
| Alobaid, A | 1 |
| Rasheed, A | 1 |
| Soliman, I | 1 |
| Wendel Garcia, PD | 1 |
| Fumeaux, T | 1 |
| Guerci, P | 1 |
| Heuberger, DM | 1 |
| Montomoli, J | 2 |
| Roche-Campo, F | 1 |
| Schuepbach, RA | 1 |
| Hilty, MP | 1 |
| Poloni, TE | 1 |
| Carlos, AF | 1 |
| Cairati, M | 1 |
| Cutaia, C | 1 |
| Medici, V | 1 |
| Marelli, E | 1 |
| Ferrari, D | 1 |
| Galli, A | 1 |
| Bognetti, P | 1 |
| Davin, A | 1 |
| Cirrincione, A | 1 |
| Ceretti, A | 1 |
| Cereda, C | 1 |
| Ceroni, M | 1 |
| Tronconi, L | 1 |
| Vitali, S | 1 |
| Guaita, A | 1 |
| Leeds, JS | 1 |
| Raviprakash, V | 1 |
| Jacques, T | 1 |
| Scanlon, N | 1 |
| Cundall, J | 1 |
| Leeds, CM | 1 |
| Riva, A | 1 |
| Gray, EH | 1 |
| Azarian, S | 1 |
| Zamalloa, A | 1 |
| McPhail, MJW | 1 |
| Vincent, RP | 1 |
| Williams, R | 1 |
| Chokshi, S | 1 |
| Patel, VC | 1 |
| Edwards, LA | 1 |
| Alqarawi, W | 1 |
| Birnie, DH | 1 |
| Golian, M | 1 |
| Nair, GM | 1 |
| Nery, PB | 1 |
| Klein, A | 1 |
| Davis, DR | 1 |
| Sadek, MM | 1 |
| Neilipovitz, D | 1 |
| Johnson, CB | 1 |
| Green, MS | 1 |
| Redpath, C | 1 |
| Miller, DC | 1 |
| Beamer, P | 1 |
| Billheimer, D | 1 |
| Subbian, V | 1 |
| Sorooshian, A | 1 |
| Campbell, BS | 1 |
| Mosier, JM | 1 |
| Novaretti, JV | 1 |
| Astur, DC | 1 |
| Cavalcante, ELB | 1 |
| Kaleka, CC | 1 |
| Amaro, JT | 1 |
| Cohen, M | 1 |
| Huang, W | 1 |
| Li, T | 1 |
| Ling, Y | 1 |
| Qian, ZP | 1 |
| Zhang, YY | 1 |
| Huang, D | 1 |
| Xu, SB | 1 |
| Liu, XH | 1 |
| Xia, L | 1 |
| Yang, Y | 3 |
| Lu, SH | 1 |
| Lu, HZ | 1 |
| Zhang, R | 2 |
| Ma, JX | 1 |
| Tang, S | 1 |
| Li, CM | 1 |
| Wan, J | 1 |
| Wang, JF | 1 |
| Ma, JQ | 1 |
| Luo, JJ | 1 |
| Chen, HY | 2 |
| Mi, SL | 1 |
| Chen, SY | 1 |
| Su, YG | 1 |
| Ge, JB | 1 |
| Milheiro, SA | 1 |
| Gonçalves, J | 1 |
| Lopes, RMRM | 1 |
| Madureira, M | 1 |
| Lobo, L | 1 |
| Lopes, A | 1 |
| Nogueira, F | 1 |
| Fontinha, D | 1 |
| Prudêncio, M | 1 |
| M Piedade, MF | 1 |
| Pinto, SN | 1 |
| Florindo, PR | 1 |
| Moreira, R | 1 |
| Castillo-Lora, J | 1 |
| Delley, MF | 1 |
| Laga, SM | 1 |
| Mayer, JM | 1 |
| Sutjarit, N | 1 |
| Thongon, N | 1 |
| Weerachayaphorn, J | 1 |
| Piyachaturawat, P | 1 |
| Suksamrarn, A | 1 |
| Suksen, K | 1 |
| Papachristou, DJ | 1 |
| Blair, HC | 1 |
| Hu, Y | 1 |
| Shen, P | 1 |
| Zeng, N | 1 |
| Wang, L | 3 |
| Yan, D | 1 |
| Cui, L | 1 |
| Yang, K | 2 |
| Zhai, C | 1 |
| Yang, M | 1 |
| Lao, X | 1 |
| Sun, J | 1 |
| Ma, N | 1 |
| Wang, S | 1 |
| Ye, W | 1 |
| Guo, P | 1 |
| Rahimi, S | 1 |
| Singh, MP | 1 |
| Gupta, J | 1 |
| Nakanishi, I | 1 |
| Ohkubo, K | 1 |
| Shoji, Y | 1 |
| Fujitaka, Y | 1 |
| Shimoda, K | 1 |
| Matsumoto, KI | 1 |
| Fukuhara, K | 1 |
| Hamada, H | 1 |
| van der Boom, T | 1 |
| Gruppen, EG | 1 |
| Lefrandt, JD | 1 |
| Connelly, MA | 1 |
| Links, TP | 1 |
| Dullaart, RPF | 1 |
| Berry, JD | 1 |
| Bedlack, R | 1 |
| Mathews, D | 1 |
| Agnese, W | 1 |
| Apple, S | 1 |
| Meloncelli, S | 1 |
| Divizia, M | 1 |
| Germani, G | 1 |
| Adefegha, SA | 1 |
| Bottari, NB | 1 |
| Leal, DB | 1 |
| de Andrade, CM | 1 |
| Schetinger, MR | 1 |
| Martínez-Velasco, A | 1 |
| Perez-Ortiz, AC | 1 |
| Antonio-Aguirre, B | 1 |
| Martínez-Villaseñor, L | 1 |
| Lira-Romero, E | 1 |
| Palacio-Pastrana, C | 1 |
| Zenteno, JC | 1 |
| Ramirez, I | 1 |
| Zepeda-Palacio, C | 1 |
| Mendoza-Velásquez, C | 1 |
| Camacho-Ordóñez, A | 1 |
| Ortiz Bibriesca, DM | 1 |
| Estrada-Mena, FJ | 1 |
| Martin, BL | 1 |
| Thompson, LC | 1 |
| Kim, YH | 2 |
| Snow, SJ | 1 |
| Schladweiler, MC | 1 |
| Phillips, P | 1 |
| Harmon, M | 1 |
| King, C | 1 |
| Richards, J | 1 |
| George, I | 1 |
| Haykal-Coates, N | 1 |
| Gilmour, MI | 1 |
| Kodavanti, UP | 1 |
| Hazari, MS | 1 |
| Farraj, AK | 1 |
| Shen, Z | 1 |
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| Gao, K | 1 |
| Lazar, S | 1 |
| Wurtzel, JGT | 1 |
| Ma, P | 1 |
| Goldfinger, LE | 1 |
| Vukelic, M | 1 |
| Laloo, A | 1 |
| Kyttaris, VC | 1 |
| Chen, R | 1 |
| Chen, J | 2 |
| Xun, J | 1 |
| Hu, Z | 1 |
| Huang, Q | 2 |
| Steinhart, C | 1 |
| Shen, Y | 1 |
| Lu, H | 1 |
| Mansuri, A | 1 |
| Lokhande, K | 1 |
| Kore, S | 1 |
| Gaikwad, S | 1 |
| Nawani, N | 1 |
| Swamy, KV | 1 |
| Junnarkar, M | 1 |
| Pawar, S | 1 |
| Shaheen, MY | 1 |
| Basudan, AM | 1 |
| Niazy, AA | 1 |
| van den Beucken, JJJP | 1 |
| Jansen, JA | 1 |
| Alghamdi, HS | 1 |
| Gao, Q | 2 |
| Guo, X | 1 |
| Cao, Y | 1 |
| Jia, X | 1 |
| Xu, S | 1 |
| Lu, C | 2 |
| Zhu, H | 2 |
| Melku, M | 1 |
| Abebe, G | 1 |
| Teketel, A | 1 |
| Asrie, F | 1 |
| Yalew, A | 1 |
| Biadgo, B | 1 |
| Kassa, E | 1 |
| Damtie, D | 1 |
| Anlay, DZ | 1 |
| Ahmed, MFE | 1 |
| Ramadan, H | 1 |
| Seinige, D | 1 |
| Kehrenberg, C | 1 |
| Abd El-Wahab, A | 1 |
| Volkmann, N | 1 |
| Kemper, N | 1 |
| Schulz, J | 1 |
| Hu, MY | 1 |
| Wu, YN | 1 |
| McEvoy, MP | 1 |
| Wang, YF | 1 |
| Cong, WL | 1 |
| Liu, LP | 1 |
| Li, XX | 1 |
| Zhou, CL | 1 |
| Chen, WM | 1 |
| Wei, KL | 1 |
| Tung, SY | 1 |
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| Yen, CW | 1 |
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| Hung, CH | 1 |
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| Elashiry, MM | 1 |
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| Tian, F | 1 |
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| Tay, FR | 1 |
| Cutler, CW | 1 |
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| Jobling, MG | 1 |
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| McVeigh, AL | 1 |
| Gregory, MJ | 1 |
| Maves, RC | 1 |
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| Holmes, RK | 1 |
| Savarino, SJ | 1 |
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| Palevsky, PM | 1 |
| Kaufman, JS | 1 |
| Thiessen Philbrook, H | 1 |
| Weisbord, SD | 1 |
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| John, CM | 1 |
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| Jarvis, GA | 1 |
| Zhu, Y | 1 |
| Kilburn, S | 1 |
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| Chaturvedi, S | 1 |
| Shaw, KJ | 1 |
| Chaturvedi, V | 1 |
| Kong, X | 1 |
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| Feng, X | 1 |
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| Feng, J | 1 |
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| Nguyen, F | 1 |
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| Perry, LM | 1 |
| Soberman, D | 1 |
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| Alferiev, IS | 1 |
| Chorny, M | 1 |
| Brodeur, GM | 1 |
| Gao, X | 2 |
| Cheng, YH | 1 |
| Enten, GA | 1 |
| DeSantis, AJ | 1 |
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| Kim, DY | 1 |
| Choi, MJ | 1 |
| Ko, TK | 1 |
| Lee, NH | 1 |
| Kim, OH | 1 |
| Cheon, HG | 1 |
| Cai, H | 1 |
| Yip, V | 1 |
| Lee, MV | 1 |
| Wong, S | 1 |
| Saad, O | 1 |
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| Khojasteh, SC | 1 |
| Kamath, AV | 1 |
| Shen, BQ | 1 |
| Cuypers, ML | 1 |
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| Gillent, E | 1 |
| Bonnaillie, P | 1 |
| Saunders, K | 1 |
| Beckers, C | 1 |
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| Dell'Aiera, S | 1 |
| Ungell, AL | 1 |
| Nicolaï, J | 1 |
| Knapp, AK | 1 |
| Chen, A | 1 |
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| Carroll, CJW | 1 |
| Gray, JE | 1 |
| Hoffman, AM | 1 |
| Li, X | 4 |
| Post, AK | 1 |
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| Wang, YD | 1 |
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| Xin, ZM | 1 |
| Han, TT | 1 |
| Wang, ZG | 1 |
| Chen, L | 1 |
| Cai, C | 1 |
| Zhang, Y | 4 |
| Ba, D | 1 |
| Wen, S | 1 |
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| Lv, W | 1 |
| Cheng, G | 1 |
| Li, N | 1 |
| Yue, XY | 1 |
| Chu, WJ | 1 |
| Chen, Q | 1 |
| Choi, ES | 1 |
| Zhao, X | 3 |
| Zhou, HD | 1 |
| Sun, XF | 1 |
| Sharma, S | 2 |
| Chhoker, S | 1 |
| Xie, C | 1 |
| Ong, EWY | 1 |
| Tan, ZK | 1 |
| Evans, S | 1 |
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| Barger, PM | 1 |
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| Liu, J | 2 |
| Huang, Y | 1 |
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| Yu, X | 1 |
| Feng, B | 1 |
| Liu, D | 1 |
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| Mendes, GC | 1 |
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| Ge, D | 1 |
| Wang, WM | 1 |
| Fontes, EPB | 1 |
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| Mei-Li, C | 1 |
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| Jian-Bo, Z | 1 |
| Dan-Li, W | 1 |
| Zhi-Min, G | 1 |
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| Fornari, VJ | 1 |
| Hartmann, MSM | 1 |
| Vanni, JR | 1 |
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| Zaia, AA | 1 |
| Nakanjako, D | 1 |
| Zalwango, F | 1 |
| Wairagala, P | 1 |
| Luboga, F | 1 |
| Andia Biraro, I | 1 |
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| Jia, Y | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries[NCT02132247] | Phase 4 | 104 participants (Actual) | Interventional | 2014-05-31 | Completed | ||
| An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study Of Repeat-Doses Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain[NCT00726388] | Phase 3 | 1,050 participants (Actual) | Interventional | 2008-09-15 | Completed | ||
| Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery[NCT00448110] | Phase 3 | 331 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery[NCT00507026] | Phase 3 | 277 participants (Actual) | Interventional | 2007-07-25 | Completed | ||
| Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.[NCT04378959] | 76 participants (Actual) | Interventional | 2021-02-01 | Completed | |||
| A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain[NCT01335724] | Phase 4 | 72 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries[NCT03472339] | Phase 4 | 300 participants (Anticipated) | Interventional | 2018-01-15 | Recruiting | ||
| The Effects of Spinal Manipulative Therapy on Postactivation Potentiation[NCT02848456] | 20 participants (Actual) | Interventional | 2014-08-31 | Completed | |||
| The Influence of the Sacroiliac Joint Manipulation on Changes in the Values of the Center of Pressure in the Process of Maintaining Static Body Balance[NCT04387032] | 59 participants (Actual) | Interventional | 2019-06-15 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6. (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution
| Intervention | Units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Day1-2 | Day 3-4 | Day 5-7 | Day 8-11 | Day 12-15 | |
| Flector Patch/Age 12-16 | 0.04 | 0.06 | 0.00 | 0.06 | 0.00 |
| Flector Patch/Age 6-11 | 0.10 | 0.04 | 0.11 | 0.00 | 0.00 |
5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5. (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| No clinical improvement | Slight clinical improvement | Moderate clinical improvement | Marked clinical improvement | Normal function with no pain | |
| Flector Patch/Age 12-16 | 1 | 0 | 2 | 9 | 40 |
| Flector Patch/Age 6-11 | 1 | 0 | 2 | 2 | 47 |
"Wong-Baker FACES Scale 6-point scale:~No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5." (NCT02132247)
Timeframe: Up to 2 weeks, depending upon pain resolution
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Final Visit | |
| Flector Patch/Age 12-16 | 3.58 | 0.27 |
| Flector Patch/Age 6-11 | 3.37 | 0.12 |
(NCT02132247)
Timeframe: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
| Intervention | ng/mL (Mean) | |
|---|---|---|
| 24-hour | Final Visit | |
| Flector Patch/Age 12-16 | 1.46 | 1.11 |
| Flector Patch/Age 6-11 | 1.83 | 2.49 |
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
| Intervention | Beats per minute (Mean) |
|---|---|
| DIC075V | 2.4 |
Change from baseline in heart rate in beats per minute was reported. The heart rate was assessed after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
| Intervention | Beats per minute (Mean) |
|---|---|
| DIC075V | 3.8 |
Respiratory rate was measured after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
| Intervention | Breaths per minute (Mean) |
|---|---|
| DIC075V | 1.0 |
Respiratory rate was measured after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
| Intervention | Breaths per minute (Mean) |
|---|---|
| DIC075V | 1.3 |
Concomitant medications were medications that were taken concurrently on or after first dose of study drug. (NCT00726388)
Timeframe: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
| Intervention | Participants (Count of Participants) |
|---|---|
| DIC075V | 971 |
Urine parameters included gravity, glucose, protein, and bilirubin. Abnormalities were judged by the investigator. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing) up to study discharge/early termination (maximum up to Day 5)
| Intervention | Participants (Count of Participants) |
|---|---|
| DIC075V | 2 |
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing)
| Intervention | Participants (Count of Participants) |
|---|---|
| DIC075V | 14 |
12-lead ECG parameters were evaluated. Clinically significant abnormal ECG findings were based on investigator's discretion. (NCT00726388)
Timeframe: Study discharge/early termination (maximum up to Day 5)
| Intervention | Participants (Count of Participants) |
|---|---|
| DIC075V | 13 |
Change from baseline in SBP and DBP in mmHg was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
| Intervention | mmHg (Mean) | |
|---|---|---|
| SBP | DBP | |
| DIC075V | 0.2 | 4.4 |
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in millimeter of mercury (mmHg) was reported. The blood pressure was assessed after the participant had taken rest for 5 minutes. (NCT00726388)
Timeframe: Baseline (Day 1, immediately before dosing), Study discharge/early termination (maximum up to 5 days)
| Intervention | mmHg (Mean) | |
|---|---|---|
| SBP | DBP | |
| DIC075V | -2.2 | -0.5 |
Physical examination included the assessment of general appearance, skin; HEENT; neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion. (NCT00726388)
Timeframe: Clinic follow-up visit (4-10 days after last dose, maximum up to 15 days)
| Intervention | Participants (Count of Participants) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General appearance | Skin | HEENT | Neck/Thyroid | Oral Cavity | Lymph Nodes | Cardiovascular | Lungs | Breasts | Abdomen | Genitourinary | Neurologic | Joints/Extremities | |
| DIC075V | 8 | 13 | 2 | 1 | 0 | 0 | 5 | 5 | 0 | 12 | 1 | 5 | 41 |
Physical examination included the assessment of general appearance, skin; head, ears, eyes, nose, and throat (HEENT); neck/thyroid; oral cavity; lymph nodes; cardiovascular; lungs; abdomen; genitourinary; neurologic and joints/extremities. Clinically significant physical examination findings were based on investigator's discretion. (NCT00726388)
Timeframe: Screening (0 to 21 days prior to surgery)
| Intervention | Participants (Count of Participants) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General Appearance | Skin | HEENT | Neck/Thyroid | Oral Cavity | Lymph Nodes | Cardiovascular | Lungs | Breasts | Abdomen | Genitourinary | Neurologic | Joints/Extremities | |
| DIC075V | 8 | 3 | 7 | 1 | 2 | 0 | 3 | 0 | 0 | 29 | 32 | 10 | 295 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study. (NCT00726388)
Timeframe: Day 1 of dosing up to maximum of 37 days after last dose (maximum up to 42 days)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| TEAEs | SAEs | |
| DIC075V | 823 | 73 |
"Wound assessment had 6 questions, completed by investigator/sub-investigator. Question related to extent of healing; extent and degree of inflammation and extent of drainage had options: much better than expected, better than expected, normal, slower than expected, and much slower than expected. Question related to separation of surgical incision had options: no separation, barely detectible separation, localized separation, mostly separated, and complete separation (dehiscence). Question related to infection at surgical site had options: definitely, no infection, possibly infected, probably infected, certainly infected, and abscess/gross cellulitis. Question related to prescription of postoperative systemic antibiotics had options: no, yes for prophylaxis, and yes for infection. Every question there was category Not Done for participants with no wound assessment other than the reason 'missing' and category Missing, where participants were missing for wound assessment." (NCT00726388)
Timeframe: Study discharge/early termination (maximum up to Day 5)
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Extent of healing: Much better than expected | Extent of healing: Better than expected | Extent of healing: Normal | Extent of healing: Slower than expected | Extent of healing: Much slower than expected | Extent of healing: Not done | Extent of healing: Missing | Extent and degree of Inflammation: Much better than expected | Extent and degree of inflammation: Better than expected | Extent and degree of Inflammation: Normal | Extent and degree of Inflammation: Slower than expected | Extent and degree of Inflammation: Much slower than expected | Extent and degree of inflammation: Not done | Extent and degree of inflammation: Missing | Extent of drainage: Much better than expected | Extent of drainage: Better than expected | Extent of drainage: Normal | Extent of drainage: Slower than expected | Extent of drainage: Much slower than expected | Extent of drainage: Not done | Extent of drainage: Missing | Separation of Incision: No separation | Separation of Incision: Barely detectable separation | Separation of incision: Localized separation | Separation of incision: Mostly separated | Separation of incision: Complete separation | Separation of incision: Not done | Separation of incision: Missing | Infection at surgical site: Definitely, No infection | Infection at surgical site: Possibly infected | Infection at surgical site: Probably infected | Infection at surgical site: Certainly infected | Infection at surgical site: Abscess or gross cellulitis | Infection at surgical site: Not done | Infection at surgical site: Missing | Postoperative systemic antibiotics: No | Postoperative systemic antibiotics: Yes, for prophylaxis | Postoperative systemic antibiotics: Yes, for infection | Postoperative systemic antibiotics: Not done | Postoperative systemic antibiotics: Missing | |
| DIC075V | 40 | 154 | 727 | 11 | 0 | 33 | 6 | 50 | 214 | 657 | 11 | 0 | 33 | 6 | 78 | 195 | 633 | 29 | 1 | 33 | 2 | 809 | 87 | 35 | 0 | 0 | 33 | 7 | 921 | 12 | 1 | 1 | 0 | 33 | 3 | 673 | 262 | 1 | 33 | 2 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction. (NCT00507026)
Timeframe: Over 120 hours post first dose
| Intervention | mm*hours (Mean) |
|---|---|
| Diclofenac (DIC075V) | 4835.6 |
| Ketorolac | 4359.1 |
| Placebo | 1840.5 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction. (NCT00507026)
Timeframe: Over 24 hours post first dose
| Intervention | mm*hours (Mean) |
|---|---|
| Diclofenac (DIC075V) | 577.0 |
| Ketorolac | 563.2 |
| Placebo | 28.0 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction. (NCT00507026)
Timeframe: Over 48 hours post first dose
| Intervention | mm*hours (Mean) |
|---|---|
| Diclofenac (DIC075V) | 1527.5 |
| Ketorolac | 1371.8 |
| Placebo | 400.4 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction. (NCT00507026)
Timeframe: Over 72 hours post first dose
| Intervention | mm*hours (Mean) |
|---|---|
| Diclofenac (DIC075V) | 2592.1 |
| Ketorolac | 2312.1 |
| Placebo | 836.8 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction. (NCT00507026)
Timeframe: Over 96 hours post first dose
| Intervention | mm*hours (Mean) |
|---|---|
| Diclofenac (DIC075V) | 3711.3 |
| Ketorolac | 3331.9 |
| Placebo | 1337.8 |
Time from administration of study drug to administration of rescue medication were censored at time of last pain assessment for participants who did not receive rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. (NCT00507026)
Timeframe: Maximum up to 5 days
| Intervention | Minutes (Median) |
|---|---|
| Diclofenac (DIC075V) | 220.0 |
| Ketorolac | 137.0 |
| Placebo | 51.0 |
Participants were instructed to stop the second stopwatch at the onset of meaningful pain relief after first dose. Event times of participants not reporting meaningful relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. (NCT00507026)
Timeframe: Within 6 hours of first dose on Day 1
| Intervention | Minutes (Median) |
|---|---|
| Diclofenac (DIC075V) | 41.6 |
| Ketorolac | 42.5 |
| Placebo | NA |
Participants were instructed to stop the first stopwatch at the onset of perceptible pain relief after first dose. Event times of participants not reporting perceptible relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. (NCT00507026)
Timeframe: Within 6 hours of first dose on Day 1
| Intervention | Minutes (Median) |
|---|---|
| Diclofenac (DIC075V) | 10.0 |
| Ketorolac | 14.4 |
| Placebo | 15.0 |
In this outcome measure, cumulative amount of rescue medication used over 0-24, 0-48, 0-72, 0-96, and 0-120 hours were reported. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. (NCT00507026)
Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours
| Intervention | mg (Mean) | ||||
|---|---|---|---|---|---|
| 0-24 hours | 0-48 hours | 0-72 hours | 0-96 hours | 0-120 hours | |
| Diclofenac (DIC075V) | 9.4 | 11.1 | 11.7 | 11.8 | 11.8 |
| Ketorolac | 11.5 | 15.5 | 18.0 | 18.1 | 18.1 |
| Placebo | 16.0 | 19.0 | 20.5 | 20.5 | 20.5 |
In this outcome measure, number of participants are reported according to number of times they received rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. Only those categories with at least one nonzero value are reported. (NCT00507026)
Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 - 24 Hours: 0 | 0 - 24 Hours: 1 | 0 - 24 Hours: 2 | 0 - 24 Hours: 3 | 0 - 24 Hours: 4 | 0 - 24 Hours: 5 | 0 - 24 Hours: 6 | 0 - 24 Hours: 7 | 0 - 24 Hours: 8 | 0 - 24 Hours: 9 | 0 - 24 Hours: 11 | 0 - 24 Hours: 12 | 0 - 24 Hours: 13 | 0 - 24 Hours: 14 | 0 - 24 Hours: 15 | 0-48 hours: 0 | 0-48 hours: 1 | 0-48 hours: 2 | 0-48 hours: 3 | 0-48 hours: 4 | 0-48 hours: 5 | 0-48 hours: 6 | 0-48 hours: 7 | 0-48 hours: 8 | 0-48 hours: 9 | 0-48 hours: 10 | 0-48 hours: 11 | 0-48 hours: 12 | 0-48 hours: 13 | 0-48 hours: 14 | 0-48 hours: 15 | 0-48 hours: 17 | 0-48 hours: 20 | 0-72 hours: 0 | 0-72 hours: 1 | 0-72 hours: 2 | 0-72 hours: 3 | 0-72 hours: 4 | 0-72 hours: 5 | 0-72 hours: 6 | 0-72 hours: 7 | 0-72 hours: 8 | 0-72 hours: 9 | 0-72 hours: 10 | 0-72 hours: 11 | 0-72 hours: 12 | 0-72 hours: 13 | 0-72 hours: 14 | 0-72 hours: 15 | 0-72 hours: 17 | 0-72 hours: 19 | 0-72 hours: 20 | 0-72 hours: 21 | 0-96 hours: 0 | 0-96 hours: 1 | 0-96 hours: 2 | 0-96 hours: 3 | 0-96 hours: 4 | 0-96 hours: 5 | 0-96 hours: 6 | 0-96 hours: 7 | 0-96 hours: 8 | 0-96 hours: 9 | 0-96 hours: 10 | 0-96 hours: 11 | 0-96 hours: 12 | 0-96 hours: 13 | 0-96 hours: 14 | 0-96 hours: 15 | 0-96 hours: 17 | 0-96 hours: 19 | 0-96 hours: 20 | 0-96 hours: 21 | 0-120 hours: 0 | 0-120 hours: 1 | 0-120 hours: 2 | 0-120 hours: 3 | 0-120 hours: 4 | 0-120 hours: 5 | 0-120 hours: 6 | 0-120 hours: 7 | 0-120 hours: 8 | 0-120 hours: 9 | 0-120 hours: 10 | 0-120 hours: 11 | 0-120 hours: 12 | 0-120 hours: 13 | 0-120 hours: 14 | 0-120 hours: 15 | 0-120 hours: 17 | 0-120 hours: 19 | 0-120 hours: 20 | 0-120 hours: 21 | |
| Diclofenac (DIC075V) | 39 | 26 | 26 | 19 | 8 | 9 | 7 | 3 | 2 | 3 | 1 | 1 | 1 | 0 | 0 | 38 | 23 | 24 | 14 | 11 | 7 | 8 | 6 | 3 | 4 | 2 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 38 | 23 | 22 | 15 | 11 | 6 | 8 | 4 | 4 | 3 | 5 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 38 | 23 | 22 | 15 | 11 | 6 | 7 | 5 | 3 | 3 | 5 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 38 | 23 | 22 | 15 | 11 | 6 | 7 | 5 | 3 | 3 | 5 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ketorolac | 17 | 6 | 9 | 8 | 4 | 3 | 3 | 5 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 16 | 5 | 10 | 5 | 2 | 3 | 2 | 4 | 3 | 4 | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 16 | 5 | 10 | 5 | 2 | 2 | 2 | 4 | 2 | 1 | 4 | 2 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 16 | 5 | 10 | 5 | 2 | 2 | 2 | 4 | 2 | 1 | 3 | 3 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 16 | 5 | 10 | 5 | 2 | 2 | 2 | 4 | 2 | 1 | 3 | 2 | 2 | 1 | 0 | 2 | 1 | 0 | 0 | 0 |
| Placebo | 4 | 7 | 6 | 11 | 9 | 9 | 3 | 7 | 4 | 4 | 3 | 2 | 1 | 1 | 1 | 14 | 7 | 6 | 10 | 3 | 8 | 5 | 8 | 3 | 5 | 0 | 5 | 3 | 1 | 1 | 1 | 1 | 1 | 4 | 7 | 6 | 10 | 3 | 5 | 7 | 6 | 2 | 9 | 9 | 0 | 2 | 3 | 1 | 2 | 0 | 1 | 1 | 1 | 4 | 7 | 6 | 10 | 3 | 5 | 6 | 7 | 2 | 9 | 0 | 2 | 3 | 1 | 2 | 2 | 0 | 1 | 1 | 1 | 4 | 7 | 6 | 10 | 3 | 5 | 6 | 7 | 2 | 9 | 0 | 2 | 3 | 1 | 2 | 2 | 0 | 1 | 1 | 1 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). PID score range at any post dose (post baseline) evaluation time point was -100 to 100. A positive difference score is indicative of improvement. (NCT00507026)
Timeframe: Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose
| Intervention | mm (Mean) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At 5 minutes | At 10 minutes | At 15 minutes | At 30 minutes | At 45 minutes | At 1 hour | At 2 hours | At 3 hours | At 5 hours | At 6 hours | At 9 hours | At 12 hours | At 15 hours | At 18 hours | At 21 hours | At 24 hours | At 48 hours | At 72 hours | At 120 hours | |
| Placebo | 1.2 | 2.4 | 2.2 | 2.6 | -1.2 | -4.2 | -7.8 | -8.9 | -7.3 | -6.1 | -1.8 | 1.4 | 1.1 | 8.7 | 8.8 | 12.9 | 19.4 | 20.3 | 20.9 |
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). PID score range at any post dose (post baseline) evaluation time point was -100 to 100. A positive difference score is indicative of improvement. (NCT00507026)
Timeframe: Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose
| Intervention | mm (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At 5 minutes | At 10 minutes | At 15 minutes | At 30 minutes | At 45 minutes | At 1 hour | At 2 hours | At 3 hours | At 5 hours | At 6 hours | At 9 hours | At 12 hours | At 15 hours | At 18 hours | At 21 hours | At 24 hours | At 48 hours | At 72 hours | At 96 hours | At 120 hours | |
| Diclofenac (DIC075V) | 5.2 | 9.1 | 13.4 | 17.7 | 18.5 | 18.7 | 17.3 | 13.5 | 10.8 | 12.6 | 23.6 | 23.4 | 28.5 | 30.2 | 36.3 | 31.8 | 42.9 | 47.0 | 46.8 | 46.9 |
| Ketorolac | 3.2 | 5.5 | 9.8 | 16.7 | 18.4 | 19.7 | 16.9 | 14.7 | 15.1 | 12.5 | 21.3 | 23.7 | 23.2 | 30.1 | 39.1 | 27.5 | 35.5 | 41.0 | 43.0 | 42.9 |
Participants global evaluation of study medication was accessed on a scale ranging from scale 0 to 4 where 0= poor, 1= fair, 2= good, 3= very good, 4= excellent where higher score represented better outcome. (NCT00507026)
Timeframe: 0-24, 0-48, 0-120 hours post-dose
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| 0-24 Hours | 0-48 Hours | 0-120 Hours | |
| Diclofenac (DIC075V) | 2.6 | 2.9 | 2.9 |
| Ketorolac | 2.4 | 2.6 | 2.6 |
| Placebo | 1.1 | 1.9 | 1.3 |
Pain intensity was measured on a 0 to 100 mm VAS, larger values indicate greater pain intensity. In this outcome measure, percentage of participants attaining >= 30 % reduction in pain intensity from baseline to specified time points was reported. (NCT00507026)
Timeframe: Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose
| Intervention | Percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| At 5 minutes | At 30 minutes | At 1 hour | At 24 hours | At 48 hours | At 72 hours | At 90 hours | At 120 hours | |
| Diclofenac (DIC075V) | 13.8 | 43.4 | 44.8 | 62.1 | 75.2 | 80.0 | 80.0 | 80.7 |
| Ketorolac | 10.0 | 35.0 | 41.7 | 56.7 | 63.3 | 71.7 | 75.0 | 75.0 |
| Placebo | 8.3 | 25.0 | 15.3 | 31.09 | 41.7 | 41.7 | 43.1 | 43.1 |
Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. TOTPAR over specified time interval was calculated as area under pain relief curve over specified time intervals using trapezoidal approximation. For 0-24 hours score range was 0-2400, for 0-48 hours score range was 0- 4800, for 0-96 hours score range was 0-9600 and for 0-120 hours score range was 0-12000. Higher TOTPAR values indicated more relief. (NCT00507026)
Timeframe: 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose
| Intervention | mm*hours (Mean) | ||||
|---|---|---|---|---|---|
| 0-24 hours | 0-48 hours | 0-72 hours | 0-96 hours | 0-120 hours | |
| Diclofenac (DIC075V) | 1177.6 | 2768.3 | 4471.0 | 6252.2 | 8042.5 |
| Ketorolac | 1065.4 | 2453.8 | 3983.6 | 5575.7 | 7178.0 |
| Placebo | 484.7 | 1327.9 | 2214.6 | 3159.4 | 4105.4 |
Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. (NCT00507026)
Timeframe: 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose
| Intervention | mm (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At 5 minutes | At 10 minutes | At 15 minutes | At 30 minutes | At 45 minutes | At 1 hour | At 2 hours | At 3 hours | At 5 hours | At 6 hours | At 9 hours | At 12 hours | At 15 hours | At 18 hours | At 21 hours | At 24 hours | At 48 hours | At 72 hours | At 96 hours | At 120 hours | |
| Diclofenac (DIC075V) | 21.9 | 27.1 | 33.5 | 39.7 | 41.6 | 40.0 | 35.3 | 33.5 | 28.8 | 36.7 | 49.5 | 51.6 | 55.7 | 56.6 | 63.6 | 59.7 | 69.4 | 74.4 | 74.6 | 74.6 |
| Ketorolac | 17.9 | 23.6 | 27.2 | 33.9 | 33.3 | 37.8 | 33.2 | 29.5 | 31.0 | 33.9 | 39.4 | 46.3 | 45.9 | 53.6 | 63.2 | 53.4 | 60.8 | 64.8 | 67.0 | 66.9 |
| Placebo | 15.3 | 19.0 | 21.6 | 23.1 | 19.9 | 17.1 | 10.1 | 8.0 | 8.0 | 12.6 | 17.5 | 21.6 | 21.4 | 28.3 | 27.4 | 32.5 | 38.2 | 38.8 | 39.4 | 39.4 |
"Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst" (NCT01335724)
Timeframe: 96h
| Intervention | Total Score (Mean) |
|---|---|
| Diclofenac Diethylamine 1.16% Gel | 2.8 |
| Placebo Gel | 14.6 |
"Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain." (NCT01335724)
Timeframe: 96h
| Intervention | mm (Mean) |
|---|---|
| Diclofenac Diethylamine 1.16% Gel | 1.2 |
| Placebo Gel | 19.2 |
"Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain." (NCT01335724)
Timeframe: 48 h
| Intervention | mm (Mean) |
|---|---|
| Diclofenac Diethylamine 1.16% Gel | 19.5 |
| Placebo Gel | 56.9 |
11 reviews available for diclofenac and Acute Pain
| Article | Year |
|---|---|
Management of Acute Pain From Non-Low Back, Musculoskeletal Injuries : A Systematic Review and Network Meta-analysis of Randomized Trials.
Topics: Acetaminophen; Acute Pain; Administration, Oral; Administration, Topical; Analgesics, Opioid; Anti-I | 2020 |
Topics: 3T3-L1 Cells; A Kinase Anchor Proteins; Acetates; Achilles Tendon; Acute Kidney Injury; Acute Pain; | 2022 |
Single-dose intravenous ketorolac for acute postoperative pain in adults.
Topics: Acute Pain; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Bias; Diclofenac; Hu | 2021 |
Topical analgesics for acute and chronic pain in adults - an overview of Cochrane Reviews.
Topics: Acute Pain; Adult; Analgesics; Arthritis, Rheumatoid; Capsaicin; Chronic Pain; Diclofenac; Humans; K | 2017 |
Single-dose intravenous diclofenac for acute postoperative pain in adults.
Topics: Acute Pain; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; | 2018 |
Caffeine as an analgesic adjuvant for acute pain in adults.
Topics: Acetaminophen; Acute Pain; Adolescent; Adult; Aged; Analgesics; Caffeine; Chemotherapy, Adjuvant; Di | 2014 |
Low-dose SoluMatrix diclofenac : a review of safety across two Phase III studies in patients with acute and osteoarthritis pain.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials, Phase III as Topic; Diclofenac | 2015 |
Single dose oral diclofenac for acute postoperative pain in adults.
Topics: Acute Pain; Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Chemistry, Pharmac | 2015 |
Topical NSAIDs for Acute Musculoskeletal Pain in Adults.
Topics: Acute Pain; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Ib | 2016 |
Diclofenac Sodium Bolus Injection (Dyloject(TM)): A Review in Acute Pain Management.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; beta-Cyclode | 2016 |
Lumiracoxib for acute postoperative dental pain: a systematic review of randomized clinical trials.
Topics: Acute Pain; Anti-Inflammatory Agents; Cyclooxygenase 2 Inhibitors; Diclofenac; Humans; Pain, Postope | 2011 |
17 trials available for diclofenac and Acute Pain
| Article | Year |
|---|---|
Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial.
Topics: Acute Pain; Administration, Topical; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Child; Dic | 2022 |
Efficacy and safety of Diclofenac sodium plaster in patients with acute pain of the limbs: a randomized, placebo and active-controlled, double-blind, parallel-group trial.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Soft T | 2023 |
A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Inject | 2023 |
Topics: 3T3-L1 Cells; A Kinase Anchor Proteins; Acetates; Achilles Tendon; Acute Kidney Injury; Acute Pain; | 2022 |
A randomized controlled trial of ibuprofen versus ketorolac versus diclofenac for acute, nonradicular low back pain.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Ibupro | 2021 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Safety of Injectable HPβCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Age Factors; Aged; Anti-Inflammatory Agents, Non-Ster | 2018 |
Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial.
Topics: Acute Pain; Administration, Oral; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; | 2019 |
Efficacy and safety of low dose subcutaneous diclofenac in the management of acute pain: a randomized double-blind trial.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Adolescent; Adult; Aged; Analysis of Variance; Anti-I | 2014 |
Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.
Topics: Acute Pain; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroi | 2013 |
Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.
Topics: Acute Pain; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroi | 2013 |
Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.
Topics: Acute Pain; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroi | 2013 |
Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.
Topics: Acute Pain; Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroi | 2013 |
Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study.
Topics: Acute Pain; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Bli | 2013 |
[Effect of nonsteroidal anti-inflammatory drugs on the indicators of cardiovascular risk in patients with acute nonspecific back pain].
Topics: Acute Pain; Aged; Anti-Inflammatory Agents, Non-Steroidal; Back Pain; Cardiovascular Diseases; Cyclo | 2015 |
Cardiovascular safety of hydroxypropyl-β-cyclodextrin-diclofenac in the management of acute postsurgical pain: a pooled analysis of 2 randomized, double-blind, placebo- and active comparator-controlled phase III clinical trials.
Topics: 2-Hydroxypropyl-beta-cyclodextrin; Acute Pain; Adolescent; Adult; Aged; Anti-Inflammatory Agents, No | 2016 |
Effectiveness and safety of diclofenac epolamine topical patch 1.3% for the treatment of acute pain due to back strain: an open-label, uncontrolled study.
Topics: Acute Pain; Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroida | 2011 |
Effectiveness of diclofenac, ketorolac and etoricoxib in the treatment of acute pain from ankle fracture.
Topics: Acute Pain; Adult; Ankle Injuries; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind | 2010 |
Treatment of loin pain suspected to be renal colic with papaverine hydrochloride: a prospective double-blind randomised study.
Topics: Acute Disease; Acute Pain; Adolescent; Adult; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; D | 2012 |
A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study.
Topics: Abdomen; Acute Pain; Adult; Chemistry, Pharmaceutical; Diclofenac; Dose-Response Relationship, Drug; | 2012 |
A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study.
Topics: Abdomen; Acute Pain; Adult; Chemistry, Pharmaceutical; Diclofenac; Dose-Response Relationship, Drug; | 2012 |
A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study.
Topics: Abdomen; Acute Pain; Adult; Chemistry, Pharmaceutical; Diclofenac; Dose-Response Relationship, Drug; | 2012 |
A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study.
Topics: Abdomen; Acute Pain; Adult; Chemistry, Pharmaceutical; Diclofenac; Dose-Response Relationship, Drug; | 2012 |
Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo.
Topics: Absenteeism; Acetaminophen; Acute Pain; Adolescent; Adult; Ambulatory Care; Anti-Inflammatory Agents | 2013 |
Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo.
Topics: Absenteeism; Acetaminophen; Acute Pain; Adolescent; Adult; Ambulatory Care; Anti-Inflammatory Agents | 2013 |
Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo.
Topics: Absenteeism; Acetaminophen; Acute Pain; Adolescent; Adult; Ambulatory Care; Anti-Inflammatory Agents | 2013 |
Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo.
Topics: Absenteeism; Acetaminophen; Acute Pain; Adolescent; Adult; Ambulatory Care; Anti-Inflammatory Agents | 2013 |
13 other studies available for diclofenac and Acute Pain
| Article | Year |
|---|---|
[Clinical experience with the use of a fixed combination of diclofenac and orphenadrine in the treatment of acute pain syndrome].
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Orphenadrine; Pain Measurem | 2021 |
Ibuprofen, Ketorolac, and Diclofenac Are Equivalent for the Treatment of Acute, Nonradicular Low Back Pain.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Humans; Ibupro | 2022 |
[The use of a fixed combination of diclofenac and orphenadrine in the treatment of acute pain syndrome in patients with discogenic lumbosacral radiculopathy and lumboischialgia].
Topics: Acute Pain; Back Pain; Diclofenac; Humans; Orphenadrine; Radiculopathy | 2023 |
Single-dose intravenous diclofenac for acute postoperative pain in adults: A Cochrane review summary.
Topics: Acute Pain; Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans | 2021 |
Topical NSAIDs for acute local pain relief:
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Ibuprofen; Pharmaceutical P | 2021 |
[Topical NSAIDs: ineffective or undervalued?]
Topics: Acute Pain; Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Mu | 2021 |
Aceclofenac-Galactose Conjugate: Design, Synthesis, Characterization, and Pharmacological and Toxicological Evaluations.
Topics: Acute Pain; Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Biological Avail | 2018 |
Antinociceptive synergy between diclofenac and morphine after local injection into the inflamed site.
Topics: Acute Pain; Analgesics, Opioid; Animals; Anti-Inflammatory Agents, Non-Steroidal; Behavior, Animal; | 2013 |
Low dose diclofenac (Zorvolex) for pain.
Topics: Acute Pain; Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans | 2014 |
Investigation of mucus obtained from different fish species on the acute pain induced with scalpel incision in paw of rats.
Topics: Acute Pain; Analgesics; Animals; Antioxidants; Cyclooxygenase 2; Diclofenac; Fishes; Gene Expression | 2016 |
Safety and efficacy of low doses of diclofenac on acute pain in the emergency setting.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Diclofenac; Humans; Ri | 2016 |
Assessing carrageenan-induced locomotor activity impairment in rats: comparison with evoked endpoint of acute inflammatory pain.
Topics: Acute Pain; Adrenergic Uptake Inhibitors; Amines; Amphetamine; Analgesics; Analgesics, Opioid; Anima | 2012 |
Preemptive analgesic effect of diclofenac: experimental study in rats.
Topics: Acute Pain; Animals; Anti-Inflammatory Agents, Non-Steroidal; Behavior, Animal; Diclofenac; Formalde | 2011 |