دورية أكاديمية
أعرض في EDS

PRECISE trial (Pain RElief Combination Intervention StratEgies): protocol for the clinical trial of a pregabalin-melatonin combination for fibromyalgia.

التفاصيل البيبلوغرافية
العنوان: PRECISE trial (Pain RElief Combination Intervention StratEgies): protocol for the clinical trial of a pregabalin-melatonin combination for fibromyalgia.
المؤلفون: Gilron I; Kingston Health Sciences Centre, Kingston, Ontario, Canada gilroni@queensu.ca.; Providence Care Hospital, Kingston, Ontario, Canada.; Department of Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada., DeBow C; Arcus Analytica, Halifax, Nova Scotia, Canada., Elkerdawy H; Kingston Health Sciences Centre, Kingston, Ontario, Canada., Khan JS; ANESTHESIOLOGY and Pain Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada., Salomons TV; Psychology, Queen's University, Kingston, Ontario, Canada., Duggan S; Kingston Health Sciences Centre, Kingston, Ontario, Canada.; Department of Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada., Tu D; Canadian Cancer Trials Group, Queens University at Kingston, Kingston, Ontario, Canada., Holden RR; Department of Psychology, Queen's University, Kingston, Ontario, Canada.; Department of Psychiatry, Providence Care Hospital, Kingston, Ontario, Canada., Milev R; Department of Psychology, Queen's University, Kingston, Ontario, Canada.; Department of Psychiatry, Providence Care Hospital, Kingston, Ontario, Canada., Buckley DN; Anesthesia, McMaster University, Hamilon, Ontario, Canada., Moulin DE; Clinical Neurological Sciences and Oncology, Western University, London, Ontario, Canada.
المصدر: BMJ open [BMJ Open] 2024 Jun 23; Vol. 14 (6), pp. e087180. Date of Electronic Publication: 2024 Jun 23.
نوع المنشور: Journal Article; Clinical Trial Protocol
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Fibromyalgia*/drug therapy , Melatonin*/therapeutic use , Melatonin*/administration & dosage , Pregabalin*/therapeutic use , Pregabalin*/administration & dosage , Cross-Over Studies* , Drug Therapy, Combination*, Humans ; Double-Blind Method ; Adult ; Analgesics/therapeutic use ; Analgesics/administration & dosage ; Female ; Middle Aged ; Pain Management/methods ; Randomized Controlled Trials as Topic ; Male ; Pain Measurement ; Chronic Pain/drug therapy ; Treatment Outcome
مستخلص: Introduction: Fibromyalgia is associated with chronic widespread pain and disturbed sleep. Multidisciplinary, multimodal management often includes pharmacotherapy; however, current drugs used to treat fibromyalgia provide meaningful benefit to only 30-60% of treated individuals. Combining two or more different drugs is common in clinical practice with the expectation of better efficacy, tolerability or both; however, further research is needed to identify which combinations actually provide added benefit. Thus, we are planning a clinical trial to evaluate melatonin (MLT)-pregabalin (PGB) combination in participants with fibromyalgia.
Methods and Analysis: This will be a single-centre, double-blind, randomised, double-dummy, three-period, crossover trial comparing a MLT-PGB combination to each monotherapy in 54 adult participants satisfying the 2016 American College of Rheumatology criteria for fibromyalgia. Participants will receive maximally tolerated doses of MLT, PGB and MLT-PGB combination for 6 weeks. The primary outcome will be daily pain intensity (0-10); secondary outcomes will include the Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events and other measures. Analysis of the primary and secondary outcomes will involve a linear mixed model with sequence, period, treatment, the first-order carryover and baseline pain score as fixed effects and participant as a random effect to test whether there are any treatment differences among three treatments and to estimate the least square mean of the mean daily pain intensity for each treatment, adjusting for carryover as well as period effects (ie, stability of pain levels).
Ethics and Dissemination: This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN #18278231, has been granted ethical approval by the Queen's University Health Sciences Research Ethics Board (Queen's HSREB Protocol #6040998) and is currently under review for a Clinical Trial Application to Health Canada Natural and Non-prescription Health Products Directorate. All participants will provide written informed consent prior to trial participation. Following trial completion, results will be disseminated in one or more biomedical journal publications and presented at one or more scientific meetings.
Trial Registration Number: This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN18278231.
Competing Interests: Competing interests: IG has received support from Vertex, Eli Lilly Combigene, GW Research, Eupraxia and Novaremed, and has received grants from the Canadian Institutes of Health Research, Physicians’ Services Incorporated Foundation, and Queen’s University. CD has provided paid consulting services as a patient partner to AbbVie. HE, DT, DM and SD have no conflicts to declare. RRH reports no conflict of interest. RM has received consulting and speaking honoraria from AbbVie, Eisai, Janssen, Lallemand, Lundbeck, Neonmind and Otsuka, and research grants from Brain Canada, CAN-BIND, CIHR, Janssen, Nubiyota, OBI and OMHF. JSK has received grants from Canadian Institutes of Health Research, Canadian Anesthesia Research Foundation and Rising Tide Foundation. NB has no competing interests to declare within the past 5 years. TS has received grants from the Medical Research Council UK, the Welcome Trust, the European Union, CIHR, SSHRC, the True Patriot Love Foundation and Queen’s University.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: chronic pain; clinical pharmacology; clinical trials
المشرفين على المادة: JL5DK93RCL (Melatonin)
55JG375S6M (Pregabalin)
0 (Analgesics)
تواريخ الأحداث: Date Created: 20240623 Date Completed: 20240623 Latest Revision: 20240818
رمز التحديث: 20240818
مُعرف محوري في PubMed: PMC11328632
DOI: 10.1136/bmjopen-2024-087180
PMID: 38910006
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2024-087180