Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT07186751
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average pain intensity', 'timeFrame': 'At the 4-weeks', 'description': 'The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'The worst pain intensity', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'The proportion of patients achieving pain reduction', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.'}, {'measure': 'The Revised FM Impact Questionnaire', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The Revised FM Impact Questionnaire assesses the severity of FM symptoms and their impact on daily functioning. It evaluates three linked domains: function, overall impact, and symptoms, using a 0 to10 NRS. The total score ranges from 0 to 100, with higher scores indicating greater disease burden.'}, {'measure': 'The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'BPI-S accesses pain intensity over the past 24 hours, calculated as the average of items 3 to 6 on the BPI, scored using a 0 to 10 NRS. In the NRS scale, 0 indicates no pain, while 10 represents the worst pain imaginable. The total score ranges from 0 to 40, with higher scores indicating greater pain severity. BPI-I evaluates the degree to which pain interferes with daily activities, including general activity, mood, mobility work, relationships, sleep, and pleasure. This subscale comprises 7 items, each scored from 0 (no interference) to 10 (complete interference), with a total score ranging from 0 to 70.'}, {'measure': 'The short-form 36 Health Survey (SF-36)', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The SF-36 assesses health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.'}, {'measure': 'The Medical Outcomes Study Sleep Scale (MOS)', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).'}, {'measure': 'The Beck Depression Inventory-Ⅱ (BD-Ⅱ)', 'timeFrame': 'At the weeks 1, 2, 4, and 8', 'description': 'The BD-Ⅱ evaluates the severity of depressive symptoms using a 4-point scale from 0 to 3, where 0 indicates no symptom and 3 indicates severe symptomatology. It comprises 21 items, the total score ranging from 0 to 63.'}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 8 weeks', 'description': 'The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Pregabalin', 'Venlafaxine', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32345589/', 'label': 'Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/37461044/', 'label': 'Migliorini F, Maffulli N, Eschweiler J, Baroncini A, Bell A, Colarossi G. Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):504. doi: 10.1186/s13018-023-03995-z.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/26982602/', 'label': 'Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/25294655/', 'label': 'VanderWeide LA, Smith SM, Trinkley KE. A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia. J Clin Pharm Ther. 2015;40(1):1-6. doi: 10.1111/jcpt.12216.'}]}, 'descriptionModule': {'briefSummary': 'Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;\n* Aged 18 years or older;\n* Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;\n* Numeric rating scale (NRS) score ≥ 4 at baseline;\n* Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;\n* Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;\n* Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.\n\nExclusion criteria\n\n* History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;\n* History of epilepsy, or depression requiring antidepressant medications;\n* Pregnancy or breastfeeding;\n* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;\n* With acute or chronic pain conditions other than FM.'}, 'identificationModule': {'nctId': 'NCT07186751', 'briefTitle': 'The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study', 'orgStudyIdInfo': {'id': 'KY2025-217-03-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin monotherapy group', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'EXPERIMENTAL', 'label': 'Pregabalin with venlafaxine group', 'interventionNames': ['Drug: Pregabalin with venlafaxine']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.', 'armGroupLabels': ['Pregabalin monotherapy group']}, {'name': 'Pregabalin with venlafaxine', 'type': 'DRUG', 'description': 'In the pregabalin with venlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Venlafaxine will be administered at 75 mg daily with breakfast initially. If the initial dose is well-tolerated, the dose could be further escalated by 75 mg per day after 4 days, up to a maximum of 225 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be maintained, with the expectation that tolerance to AEs will develop. If AEs become intolerable, the dose will be decreased back to the previous dose, which was defined as the maximum tolerated dose. In the combination group, dose titration of both pregabalin and desvenlafaxine will be conducted simultaneously. If AEs occur, the next dose regimen should be determined in consultation with a clinical physician.', 'armGroupLabels': ['Pregabalin with venlafaxine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Tiantan Hospital, Beijing, Beijing 100070', 'geoPoint': {'lat': 35.93305, 'lon': 111.40836}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+8613611326978'}], 'facility': 'Beijing Tiantan Hospital, Beijing, Beijing 100070', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+8613611326978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Army Medical University, PLA', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Pain Management, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}