Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)

Langford, Richard; Pogatzki-Zahn, Esther; Morte Pérez, Adelaida; Sust, Mariano; Cebrecos, Jesus; vaqué, anna; Bescós, Coro

Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)

Acute pain; Efficacy; Co-crystal

Detalles Bibliográficos
Autores:	Langford, Richard, Pogatzki-Zahn, Esther, Morte Pérez, Adelaida, Sust, Mariano, Cebrecos, Jesus, vaqué, anna, Bescós, Coro
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2024
País:	España
Institución:	Departament de Salut de la Generalitat de Catalunya (DS)
Repositorio:	Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:	oai:scientiasalut.gencat.cat:11351/11176
Acceso en línea:	https://hdl.handle.net/11351/11176
Access Level:	acceso abierto
Palabra clave:	Dolor postoperatori Pèptids opioides Analgèsics Boca - Cirurgia CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Dentistry::Surgery, Oral DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Pain, Postoperative COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::odontología::cirugía oral ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::dolor posoperatorio

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oai_identifier_str	oai:scientiasalut.gencat.cat:11351/11176
network_acronym_str	ES
network_name_str	España
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dc.title.none.fl_str_mv	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
title	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
spellingShingle	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1) Langford, Richard Dolor postoperatori Pèptids opioides Analgèsics Boca - Cirurgia CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Dentistry::Surgery, Oral DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Pain, Postoperative COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::odontología::cirugía oral ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::dolor posoperatorio
title_short	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
title_full	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
title_fullStr	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
title_full_unstemmed	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
title_sort	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)
dc.creator.none.fl_str_mv	Langford, Richard Pogatzki-Zahn, Esther Morte Pérez, Adelaida Sust, Mariano Cebrecos, Jesus vaqué, anna Bescós, Coro
author	Langford, Richard
author_facet	Langford, Richard Pogatzki-Zahn, Esther Morte Pérez, Adelaida Sust, Mariano Cebrecos, Jesus vaqué, anna Bescós, Coro
author_role	author
author2	Pogatzki-Zahn, Esther Morte Pérez, Adelaida Sust, Mariano Cebrecos, Jesus vaqué, anna Bescós, Coro
author2_role	author author author author author author
dc.contributor.none.fl_str_mv	Institut Català de la Salut [Langford R] The London Clinic, London, UK. [Pogatzki-Zahn EM] University Hospital Münster, Münster, Germany. [Morte A, Sust M, Cebrecos J, Vaqué A] ESTEVE Pharmaceuticals, Barcelona, Spain. [Bescós S] Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv	Dolor postoperatori Pèptids opioides Analgèsics Boca - Cirurgia CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Dentistry::Surgery, Oral DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Pain, Postoperative COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::odontología::cirugía oral ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::dolor posoperatorio
topic	Dolor postoperatori Pèptids opioides Analgèsics Boca - Cirurgia CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Dentistry::Surgery, Oral DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Pain, Postoperative COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::odontología::cirugía oral ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::dolor posoperatorio
description	Acute pain; Efficacy; Co-crystal
publishDate	2024
dc.date.none.fl_str_mv	2024 2024 2024
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://hdl.handle.net/11351/11176
url	https://hdl.handle.net/11351/11176
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Advances in Therapy;41 https://doi.org/10.1007/s12325-023-02744-2
dc.rights.none.fl_str_mv	Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	Adis
publisher.none.fl_str_mv	Adis
dc.source.none.fl_str_mv	Scientia reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str	Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str	Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection	Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_	1869420396137152513
spelling	Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)Langford, RichardPogatzki-Zahn, EstherMorte Pérez, AdelaidaSust, MarianoCebrecos, Jesusvaqué, annaBescós, CoroDolor postoperatoriPèptids opioidesAnalgèsicsBoca - CirurgiaCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, OpioidANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Dentistry::Surgery, OralDISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Postoperative Complications::Pain, PostoperativeCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioidesTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::odontología::cirugía oralENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::complicaciones posoperatorias::dolor posoperatorioAcute pain; Efficacy; Co-crystalDolor agut; Eficàcia; CocristallDolor agudo; Eficacia; CocristalIntroduction Co-crystal of tramadol-celecoxib (CTC) is the first analgesic co-crystal for acute pain. This completed phase 3 multicenter, double-blind trial assessed the efficacy and safety/tolerability of CTC in comparison with that of tramadol in the setting of moderate-to-severe pain up to 72 h after elective third molar extraction requiring bone removal. Methods Adults (n = 726) were assigned randomly to five groups (2:2:2:2:1): orally administered twice-daily CTC 100 mg (44 mg rac-tramadol hydrochloride/56 mg celecoxib; n = 164), 150 mg (66/84 mg; n = 160) or 200 mg (88/112 mg; n = 160); tramadol 100 mg four times daily (n = 159); or placebo four times daily (n = 83). Participants in CTC groups also received twice-daily placebo. The full analysis set included all participants who underwent randomization. The primary endpoint was the sum of pain intensity differences over 0 to 4 h (SPID0–4; visual analog scale). Key secondary endpoints included 4-h 50% responder and rescue medication use rates. Safety endpoints included adverse events (AEs), laboratory measures, and Opioid-Related Symptom Distress Scale (OR-SDS) score. Results All CTC doses were superior to placebo (P < 0.001) for primary and key secondary endpoints. All were superior to tramadol for SPID0–4 (analysis of covariance least squares mean differences [95% confidence interval]: − 37.1 [− 56.5, − 17.6], − 40.2 [− 59.7, − 20.6], and − 41.7 [− 61.2, − 22.2] for 100, 150, and 200 mg CTC, respectively; P < 0.001) and 4-h 50% responder rate. Four-hour 50% responder rates were 32.9% (CTC 100 mg), 33.8% (CTC 150 mg), 40.6% (CTC 200 mg), 20.1% (tramadol), and 7.2% (placebo). Rescue medication use was lower in the 100-mg (P = 0.013) and 200-mg (P = 0.003) CTC groups versus tramadol group. AE incidence and OR-SDS scores were highest for tramadol alone. Conclusions CTC demonstrated superior pain relief compared with tramadol or placebo, as well as an improved benefit/risk profile versus tramadol. Trial registration ClinicalTrials.gov identifier, NCT02982161; EudraCT number, 2016-000592-24.The study was sponsored by Mundipharma Research GmbH & Co. KG (Limburg, Germany) and bioanalytical analysis was performed by ESTEVE Pharmaceuticals S.A. (Barcelona, Spain), who invented and codeveloped CTC. CTC is now under development by ESTEVE Pharmaceuticals S.A. Scientists employed by the funder and ESTEVE Pharmaceuticals S.A. participated in the design and conduct of the study, data review and interpretation, and drafting of the article. Funding for the journal’s Rapid Service and Open Access Fees was provided by ESTEVE Pharmaceuticals S.A.AdisInstitut Català de la Salut[Langford R] The London Clinic, London, UK. [Pogatzki-Zahn EM] University Hospital Münster, Münster, Germany. [Morte A, Sust M, Cebrecos J, Vaqué A] ESTEVE Pharmaceuticals, Barcelona, Spain. [Bescós S] Vall d’Hebron Hospital Universitari, Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/11176Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésAdvances in Therapy;41https://doi.org/10.1007/s12325-023-02744-2Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/111762026-06-12T09:38:37Z
score	15,81155

Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1)

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