The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
Aged more than 18 years;
Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
Agreed to sign the informed consent form.
Disqualifiers
A history of psychiatric disease;
Hypersensitivity or have contraindications to pregabalin, venlafaxine;
Pregnancy or breastfeeding;
Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;
Trial design
Design model
Parallel
Treatments tested in this trial
Pregabalin
DrugIn general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg/day, administered in two divided doses. After 7 days, the dose will be increased to 300 mg/day. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg/day.
Pregabalin with venlafaxine
DrugFor the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg/day. If well-tolerated, the dose may be increased in 75 mg/day increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg/day.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Pregabalin monotherapy groupActive comparator 1 intervention
Group B: Pregabalin with venlafaxine groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The average pain intensity
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.
Time frame
At the 4-weeksSecondary outcomes
1
The worst pain intensity
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.
Time frame
At the weeks 1, 2, 4, 8, and 122
The proportion of patients achieving pain reduction
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.
Time frame
At the weeks 1, 2, 4, 8, and 123
Dose of pregabalin and/or venlafaxine
At the aforementioned follow-up time points, the researchers will inquire about the current dosages of pregabalin and/or venlafaxine being administered to the participants. Any dose adjustments, interruptions, or discontinuations, along with the reasons will be documented in detail.
Time frame
At the weeks 1, 2, 4, 8, and 124
The Revised FM Impact Questionnaire
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.
Time frame
At the weeks 1, 2, 4, 8, and 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Collaborator
Second Affiliated Hospital of Guangxi Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Yangyuan Youyi Hospital
Collaborator
Yanbian University Hospital
Collaborator
Beijing Jianjia Rehabilitation Hospital
Collaborator
Three Gorges Hospital of Chongqing University
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
General Hospital of Ningxia Medical University
Collaborator
The First People's Hospital of Yunnan
Collaborator
Guangdong Provincial Hospital of Chinese Medicine, Zhuhai
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Source ClinicalTrials.gov